CN114224438A

CN114224438A - Physician-controlled tissue ablation in conjunction with treatment mapping of target organ images

Info

Publication number: CN114224438A
Application number: CN202111212562.9A
Authority: CN
Inventors: 尼科莱·阿尔尤里; 苏拉格·曼特里
Original assignee: Procept Biorobotics Corp
Current assignee: Procept Biorobotics Corp
Priority date: 2014-09-05
Filing date: 2015-09-04
Publication date: 2022-03-25
Also published as: EP3188662A4; CN107072591B; WO2016037137A1; CN107072591A; JP2022078207A; EP3188662A1; JP2017532095A; BR112017004431A2; US11406453B2; US20170172668A1; US20210282868A1; BR112017004431B1; JP2020096941A; JP7037592B2

Abstract

The present application relates to physician-controlled tissue ablation in combination with treatment mapping of images of a target organ. A surgical treatment device includes an elongate support, an elongate tube, and a movable endoscope having a rigid distal portion, where the rigid distal portion of the endoscope is configured to move one or more components of the device while the support remains substantially stationary. The support may include a plurality of spaced apart suction ports near the distal end to facilitate alignment with the treatment site. In many embodiments, the image guided therapy device is configured for use with an imaging apparatus. In many embodiments, a target ablation profile is provided. The target ablation profile and one or more tissue structures are displayed in the image, and the target ablation profile displayed in the image is adjusted using user input.

Description

Physician-controlled tissue ablation in conjunction with treatment mapping of target organ images

The present application is a divisional application filed on 2015, 09/04, application No. 201580059741.X, entitled "physician-controlled tissue ablation in conjunction with treatment mapping of target organ images".

Cross Reference to Related Applications

This application claims priority from the following patent applications: U.S. provisional patent application No. 41502-713.101, entitled "INTEGRATED TREATMENT MAPPING WITH ultra image" serial No. 62/046,652, filed 5/9/2014 and U.S. provisional patent application No. 41502-714.101, entitled "PHYSICIAN CONTROLLED TISSUE RESECTION METHODS AND APPARATUS", filed 5/9/2014, entitled "PHYSICIAN CONTROLLED TISSUE RESECTION METHODS AND APPARATUS", serial No. 62/046,674, the entire disclosures of which are incorporated herein by reference.

The subject matter of the present patent application relates to the following patent applications: U.S. application Ser. No. 41502-711.101 entitled "Gene Analysis and Generation of Stem Cell Methods and Apparatus" serial No. 62/046,290, filed 5/9/2014 and U.S. application Ser. No. 41502-710.102 filed 5/9/2014, entitled "Tissue Sampling and Treatment Methods and Apparatus," serial No. 62/046,274, filed 41502-710.102, the entire disclosures of which are incorporated herein by reference and are suitable for combination according to embodiments disclosed herein.

This subject of the present patent application relates to the following patent applications: U.S. provisional patent application No. 62/019,305 entitled "AUTOMATED IMAGE-GUIDED time reset AND TREATMENT," attorney docket No. 41502-708.103, filed 30/6 2014; U.S. provisional patent application No. 61/972,730 entitled "AUTOMATED IMAGE-GUIDED time reset AND TREATMENT," attorney docket No. 41502-708.102, filed 3/31 2014; U.S. provisional patent application serial No. 61/874,849, attorney docket No. 41502-708.101, entitled "AUTOMATED IMAGE-GUIDED time reset AND TREATMENT," filed on 6/9/2013; the entire disclosure of the above application is incorporated herein by reference and is suitable for combination according to the embodiments disclosed herein.

The subject matter of the present patent application also relates to the following patent applications: PCT application No. PCT/US2013/028441 entitled "AUTOMATED IMAGE-GUIDED TISSUE RESONATION AND TREATMENT" filed on 28.2.2013 [ attorney docket No. 41502-705.601 ]; and U.S. patent application Ser. No. 61/604,932 entitled "AUTOMATED IMAGE-GUIDED INTRA-ORGAN RESONATION AND TREATMENT," attorney docket No. 41502-705.101, filed 2/29/2012; 12/399,585 of publication No. US 20090227998 entitled "TISSUE ABLATION AND CAUTERY WITH OPTICAL ENERGY CARRIED IN FLUID STREAM" filed on 3, 6.2009 (attorney docket No. 41502-704.201); application with publication number US 20110184391, filed on 2/4/2010 entitled "MULTI FLUID device reset METHODS AND DEVICES," serial No. 12/700,568 [ attorney docket number 41502-703.501 ]; and 7,882,841 entitled "MINIMALLY INVASIVE METHODS AND DEVICES FOR THE TREATMENT OF state diseas" entitled "attorney docket No. 41502-703.201", entitled 2/8/2011; PCT application No. PCT/US2011/023781 entitled "MULTI FLUID device reset METHODS AND DEVICES" published on 8/4/2011/11/7505 in 2007, and published on 8/2011, the entire disclosures of which are incorporated herein by reference and are suitable for combination according to embodiments disclosed herein.

Background

Existing methods and devices for tissue removal may be less than ideal in at least some respects. Existing methods and devices for tissue removal can produce less than ideal results in at least some circumstances. Furthermore, existing methods and apparatus may be more complex than ideal and less reliable than ideal. Existing methods and apparatus may be more expensive than would be ideal, such that fewer than the desired number of people may receive beneficial treatment.

Studies related to the embodiments have shown that existing methods and apparatus for using an endoscope in surgical procedures are less than ideal in at least some respects. For example, existing methods and apparatus may be less than ideal for viewing a surgical site in at least some circumstances. Moreover, the alignment of existing treatments to the surgical site is not perfect in at least some cases. Existing surgical devices may provide less than ideal cross-sectional widths to access a surgical site, and existing devices may not be ideally configured to access a surgical access path, such as through a body lumen.

In view of the foregoing, it is desirable to provide improved methods and apparatus for tissue removal. Ideally, such devices would be easier to use, easier to align with the surgical site, smaller, more reliable, and provide improved patient outcomes.

Disclosure of Invention

Embodiments of the present disclosure provide improved methods and apparatus for treating a patient. In many embodiments, the image-guided therapy device is configured for use with an imaging apparatus. In many embodiments, a target ablation profile is provided. The target ablation profile and one or more tissue structures are displayed in the image, and the target ablation profile displayed in the image is adjusted using user input. The image-guided therapy device may be configured to provide one or more reference structures with images obtained with the imaging apparatus to allow the therapy device to be used with the imaging apparatus. The one or more reference structures may include a movable probe tip or a marker of the treatment device. In many embodiments, the treatment device is configured to move the probe tip in a calibrated movement to determine a mapping of the image to physical coordinates of the treatment probe. Calibrated movement of the probe can determine the magnification of the image and correct for errors in the magnification of the imaging probe, and can allow the imaging device to be used in a number of independent configurations and settings independent of the treatment device. The treatment device may include one or more reference markers that may be used to determine what is visible in the mapped image, and the reference markers may include one or more structures of the treatment probe. Moreover, the treatment apparatus may be configured to correct for less than ideal alignment between the treatment probe and the imaging probe to facilitate use of the imaging device and the treatment apparatus. In many embodiments, the apparatus includes a processor having instructions to adjust the image to correct for residual alignment errors. In many embodiments, the treatment probe is substantially aligned with the sagittal plane of the ultrasound probe such that the elongate shaft of the treatment probe extends within the field of view of the sagittal plane such that a substantial portion of the elongate probe appears in the sagittal image to show the targeted treatment area and the elongate probe in the sagittal image. In many embodiments, the elongate axis of the treatment probe extending within the field of view of the sagittal image may extend at a non-parallel angle to the elongate axis of the imaging probe, such that the treatment probe may appear to be tilted at an angle to the axis of the image, e.g., tilted in the sagittal image. In many embodiments, the sagittal image may be rotated such that the elongate axis of the treatment probe appears to be aligned with the axis of the sagittal image to facilitate user planning of the treatment.

In many embodiments, the treatment table is stored on a tangible medium, such as a computer readable memory. The treatment table includes a plurality of reference positions that can be used to define a treatment.

In many embodiments, a method of resecting tissue includes cutting tissue into a tissue resection profile. The tissue ablation profile is measured and the tissue is resected to the target profile in response to the measured tissue ablation profile.

Although reference is made to treatment of the prostate, the embodiments disclosed herein are well suited for combination with other applications such as endometrial ablation, uterine fibroid removal, prostate cancer, tumor removal, and any treatment requiring a catheter, and accurate 3D removal may be helpful.

Embodiments of the present disclosure provide improved methods and devices for tissue removal. In many embodiments, a surgical treatment apparatus includes: an elongate support, an elongate tube, and a moveable endoscope having a rigid distal portion, wherein the rigid distal portion of the endoscope is configured to move one or more components of the device while the support remains substantially stationary. The support may be fixedly connected to a proximal portion of the tube to add stiffness and rigidity to the elongate tube and support, and the support may be separated from the elongate tube with a gap therebetween to define a leak path outside the patient that may help inhibit over-pressurization of the surgical site. The support may extend axially beyond the tube and may include a concave side facing the tube to reduce the cross-sectional dimension. The support may include a plurality of spaced apart suction ports near the distal end to facilitate alignment with the treatment site. The suction port may be ultrasonically visible to facilitate alignment with the patient. An endoscope configured to move a distal structure of the device may provide a reduced cross-sectional size. In many embodiments, the rigid endoscope is configured to move at least a portion of the elongate tube. One or more components that move with the endoscope may include an opening for a fluid delivery channel that is held a fixed distance from the endoscope as the endoscope moves to provide improved viewing of the surgical site when fluid released from the opening causes the removed tissue to exit the distal end of the endoscope. In many embodiments, a coupling connected to a distal portion of the endoscope is connected to the fluid delivery channel to advance and retract the opening of the fluid delivery channel with the endoscope. The coupling can be configured to receive an elongated carrier that directs energy to a target and stabilizes a distal end of the elongated carrier. While the fluid delivery channel can be configured in a number of ways, in many embodiments the elongate telescoping tube at least partially defines a fluid channel and is connected to the distal end of the endoscope with a coupling for moving the distal end of the elongate tube with an opening with the endoscope. The elongate telescoping tube can include an inner diameter sized to fit a rigid portion of the endoscope and an elongate carrier configured to direct energy to a target site. The elongate carrier may carry an energy delivery element (such as a nozzle) or an electrode that may be directed toward the treatment site. The coupling may include a guide sized to receive an elongated carrier in combination with the endoscope and allow independent movement of the carrier relative to the endoscope to treat a patient with rotational and translational movement of the carrier relative to the endoscope while the endoscope remains stationary for at least a portion of a treatment.

In many embodiments, the coupling includes a carrier channel that receives the carrier probe and an endoscope channel that receives the endoscope, each channel extending through the coupling. The channel may comprise a "figure 8" configuration with the carrier channel over the endoscope channel in a manner similar to a "figure 8" configuration. In many embodiments, at least a portion of the carrier channel and the endoscope channel overlap. In many embodiments, the carrier channel comprises a larger cross-sectional diameter than the endoscope channel.

In many embodiments, the arrangement of the support, the treatment energy carrier probe and the endoscope can allow a user to endoscopically see the support, treatment energy probe and surgical site simultaneously, which can make the device easier to align with the patient's anatomical reference.

In many embodiments, the support includes an enlarged distal tip portion, such as a spherical portion, that reduces pressure. In many embodiments, the enlarged tip provides insertion convenience. The coupling may include a tip portion adapted to be behind the enlarged distal tip when the probe is advanced to facilitate insertion into a patient.

In many embodiments, the tip of a rigid elongate support member sized to be larger in cross-section than the portion of the support member having the suction port will push the urethra outward, and the coupling will be placed straight forward so as to extend about 4mm from the tip of the angled surface of the coupling to the spherical tip. This configuration allows the practitioner to see the lower portion of the spherical tip during insertion.

In many embodiments, the endoscope includes an engagement structure that engages a complementary structure of the accessory. The complementary structure of the accessory is movable along the accessory to allow removal of the endoscope from the accessory. The complementary structure may include a component of the sliding structure (such as a bracket on a rail), for example, which may allow the user to adjust this range back and forth.

In many embodiments, the elongated support includes an opening arranged as a fiducial marker. The openings may be spaced at regular intervals (e.g. about 1cm) so that the support includes a scale that can scale the treatment. The opening may be visible with ultrasound to assist a user in positioning the elongate support within the patient. While the elongated support may be positioned in many ways, in many embodiments the markers of the support may be visible with ultrasound to enable positioning of the probe with ultrasound without the use of an endoscope. In many embodiments, the movement of the carrier probe tip including the moving energy source relative to the markers defined by the openings can be seen during treatment. In many embodiments, the opening includes an opening coupled to a suction channel of a suction source to remove severed tissue.

In many embodiments, a system user may visualize multiple markers (such as five of seven markers on an elongated support). In many embodiments, the user visualizes the five closest markers and aligns the closest markers with an anatomical reference, such as the prostate's cumulus. The closest marker of the support may correspond to a zero point of a coordinate reference system of a surgical attachment used to treat the patient.

In many embodiments, one or more of the endoscope or carrier probe is configured to align the treatment with an anatomical reference, such as the prostate's cumulus. The cumulus may include a bulge in the fundus of the prostatic portion of the urethra where the vas deferens enters the urethra, which may be visualized with ultrasound or endoscopy. In many embodiments, the adjustable endoscope includes an adjustable range that can be advanced and retracted. The adjustable range may include mechanical stops that limit proximal movement of the range so that the distal end of the endoscope may be aligned with the seminal vesicle to align a reference frame of the image-guided therapy with an anatomical reference, such as the seminal vesicle. Alternatively or in combination, the energy source carried on the probe may be aligned with a reference structure such as a hillock. In many embodiments, circuitry coupled to the probe is configured to place the probe at a location corresponding to an axial boundary of the treatment to align the treatment device with the surgical target site. The axial boundary of the treatment may be defined as the zero point of the coordinate reference system of the treatment device. In many embodiments, the null point of the treatment is adjusted to the seminal vesicle to match the procedure to the patient. Positive numbers along the treatment axis correspond to axial positions distal to the seminal hills of the treatment probe reference frame, and they approach the seminal hills from the patient anatomical reference frame.

In many embodiments, a marker of the elongate support including an opening to the aspiration channel may be aligned with an elongate ultrasound probe (such as a transrectal ultrasound probe). The marker may be aligned with the ultrasound probe in a sagittal mode (in which the sagittal plane of the ultrasound probe extends along the elongate axis of the ultrasound probe). The handpiece can be adjusted by the user to position the plurality of markers in the sagittal image. If the user does not see the marker in the sagittal image, its elongate axis may not be properly aligned with the sagittal plane of the ultrasound probe, and the ultrasound probe or one or more of the plurality of markers is adjusted to bring the plurality of markers into the sagittal ultrasound image.

In many embodiments where the ultrasound probe is in the transverse mode, the elongate support may be moon-shaped, and if the moon-shape is deformed the user may tell whether the elongate support defining the treatment axis is rotated to the left or to the right.

In many embodiments, the support including the marker is aligned to lie substantially within the sagittal ultrasound image such that several markers are visible in the ultrasound image. However, in response to the markers extending along a sagittal plane in a non-parallel configuration and at an angle relative to the ultrasound probe axis, the plurality of markers may exhibit an angular rotation in the ultrasound image. For example, rotation of the ultrasound image may be utilized to adjust such rotation of the marker.

In many embodiments, the device includes a disposable attachment having an elongated support and an elongated tube extending from the attachment having a coupling attached to a distal end. The accessory may include a handpiece configured to insert the elongate support, the elongate tube, and the carrier probe into a patient. The accessory may include a unique ID of the device, which may be provided with a tangible medium such as a bar code, magnetic strip, Radio Frequency Identifier (RFID), or computer readable medium of the accessory. In many embodiments, the accessory is configured for single use. The accessory may be configured for single use in one or more of a number of ways, such as the processor being configured to disable the accessory after the accessory is disconnected from the arm or upon receiving a signal from the processor indicating that the treatment has been completed. Single use devices have the advantage of providing greater sterilization to the patient. In many embodiments, the accessory includes circuitry to store the treatment parameters. The parameters may be stored in a non-volatile memory, such as a flash memory. The therapy parameters may include one or more parameters related to the delivery of therapeutic energy (such as fluid flow, pressure, surge, therapy location), and the parameters may be stored as a therapy table for treating the patient. In adverse events where treatment would be less than ideal, the stored parameters would be useful to find and solve the problem. The accessory may store therapy tables and other parameters, such as store fluid ablation flow rate and pressure. The accessory may comprise a portion of a kit customized based on the organ to be treated. In many embodiments, the accessory is configured to couple to oscillations of a circuit configuration including a drive coupling to align the drive coupling of the arm with the accessory.

In many embodiments, the coupling of the endoscope as described herein provides for user-friendly manual or automated use of the endoscope, and provides ease of use with interaction and retraction of the endoscope when helpful. In many embodiments, the endoscope may be retracted prior to initiating resection, and may remain retracted during tissue resection. Upon completion of the tissue resection, the endoscope can be advanced to view the surgical site without having to disassemble the arm, and the site can be viewed without manual use of the support, arm. Also, the range can be moved back and forth along the resection axis to effectively examine the resected tissue. The endoscope may be sealed over the proximal end of the rigid portion to prevent interference of fluid from the surgical site with the use of the handpiece.

In many embodiments, the encoder is provided on a long rotating treatment shaft that increases accuracy and inhibits backlash. The system may be configured to drive the elongate carrier probe until the elongate carrier probe is in position. An encoder on the shaft may provide accurate and reliable placement. The encoder may be positioned on a face of the shaft. The mode of securing to the shaft may provide greater reliability. In many embodiments, the treatment probe shaft is configured for removal. The surface intensity boundary of the encoder may be aligned with the probe tip.

In many embodiments, one or more of the handpiece or the arm includes an adjustable power input to allow the user to adjust the treatment energy in real time during treatment.

The present application also relates to the following aspects:

1) a method of treating a patient, the method comprising:

cutting the tissue into a tissue resection profile;

measuring the tissue ablation profile; and

resecting the tissue to a target profile in response to the measured tissue resection profile.

2) The method of 1), wherein a user aligns a marker with an image of the tissue ablation profile shown on a display in order to measure the tissue ablation profile.

3) The method of 1), wherein tissue is resected to the tissue resection profile using a scan pattern and a first amount of energy, the scan pattern comprising a plurality of coordinate references, and wherein tissue is resected to the target profile using the scan pattern repeated with a second amount of energy greater than the first amount of energy.

4) The method of 3), wherein the plurality of coordinate references comprises a plurality of axial coordinate references along a long axis of the target profile and a plurality of angular coordinate references of an angle of rotation about the long axis.

5) The method of 3), wherein the plurality of coordinate references are stored in a treatment table comprising a plurality of energies for the plurality of coordinate references to resect the tissue to the target contour.

6) The method of 1), wherein the tissue is resected with a fluid flow, and wherein a flow rate of the fluid is adjusted to resect the tissue to a target profile.

7) The method of 6), wherein the fluid comprises a liquid.

8) The method of 1), wherein the tissue is resected to the tissue resection profile at a first flow rate and resected to the target profile at a second flow rate, the second flow rate being greater than the first flow rate.

9) The method of 8), wherein the radial depth of tissue ablation of the probe increases linearly with flow rate through the nozzle.

10) The method of 9), wherein the first flow rate corresponds to a first amount of fluid pressure to a nozzle and the second flow rate comprises a second amount of fluid pressure to a nozzle, the second amount of fluid pressure being greater than the first amount of fluid pressure such that an amount of power of a fluid flow increases non-linearly with flow rate from the first flow rate to the second flow rate.

11) The method of 10), wherein the target profile comprises an elongated reference axis along which the nozzle travels axially and about which the nozzle rotates, and wherein the target profile comprises a radial distance such that the circumference of the target profile increases linearly with radial distance and the volume of the target profile increases non-linearly with the square of radial distance, and wherein the non-linearly increasing volume of the target profile is compensated with the non-linear increase in removal volume to linearize radial resection depth in response to flow rate.

12) The method of 1), wherein the tissue ablation profile is ablated using a first scan pattern comprising a plurality of axial and rotational positions.

13) An apparatus for treating a patient, the apparatus comprising:

a display; and

a processor coupled to the display, the processor comprising instructions to:

cutting tissue into a resection profile;

measuring the ablation profile; and

tissue is resected to the target profile in response to the measured resection profile.

14) A method of treating a patient, the method comprising:

moving the treatment probe to a plurality of physical positions; and

in response to the plurality of physical locations, a mapping of image coordinates of the image to physical coordinates is determined.

15) The method of 14), wherein the treatment probe comprises an elongate carrier coupled to a linkage, and wherein an elongate support connected to the treatment probe remains stationary in the image as the treatment probe is moved to the plurality of positions.

16) The method of 15), wherein the elongated support comprises a plurality of reference markers visible in the image.

17) The method of 16), wherein the plurality of markers includes markers spaced at regular intervals to define distances in the image.

18) The method of 16), wherein the plurality of markers comprises a plurality of openings formed in the elongated support.

19) The method of 18), wherein the plurality of openings comprises one or more of an opening connected to an aspiration channel or an opening that delivers fluid to a surgical site.

20) The method of 14), further comprising identifying a reference structure of the treatment probe at a first location of a first image and a second location of a second image.

21) The method of 14), further comprising measuring image coordinates of the treatment probe at the plurality of physical locations.

22) The method of 14), wherein the plurality of physical locations comprises a plurality of axial locations.

23) The method of 14), wherein the treatment probe comprises an energy source that releases energy from the probe at a plurality of locations.

24) The method of 14), wherein the therapy probe comprises a calibrated therapy probe configured to move to a target location.

25) The method of 14), wherein a reticle is shown on the display to illustrate calibration of the treatment probe on the display.

26) The method of 14), wherein the patient is treated with energy emitted from the movable treatment probe.

27) The method of 14), further comprising providing a treatment profile visible to a user on a display.

28) The method of 14), further comprising treating the patient in response to the mapping.

29) The method of 14), wherein the mapping function includes one or more scaling factors that scale the image coordinates to physical coordinates.

30) The method of 29), wherein the mapping function comprises one or more scale factors and a fixed aspect ratio.

31) The method of 29), wherein the mapping function includes an angle of rotation to rotate to an image shown to a user to compensate for an angle of the treatment probe relative to an imaging probe.

32) The method of 14), wherein the treatment probe includes an elongated shaft and the elongated shaft appears as a rotation in the image, and wherein the image with the treatment probe is positioned to appear aligned with a horizontal or vertical axis of the display.

33) An apparatus for treating a patient, the apparatus comprising:

a treatment probe; and

a processor comprising instructions for:

moving the treatment probe to a plurality of physical positions; and

a mapping of image coordinates to physical coordinates of the image is determined in response to the plurality of physical locations.

34) A method of resecting tissue, the method comprising:

providing a target ablation profile;

displaying the target ablation profile and the one or more tissue structures in the image; and

adjusting the target ablation profile displayed in the image.

35) An apparatus, the apparatus comprising:

a display;

a processor coupled to the display, the processor comprising instructions to:

defining a target ablation profile in response to a user input;

displaying the target ablation profile and one or more tissue structures in an image; and

adjusting the target ablation profile.

36) A method, the method comprising:

introducing a transrectal ultrasound (TRUS) probe into a patient, the TRUS probe comprising an elongate shaft;

aligning the elongate axis of the treatment probe with the elongate axis of the TRUS probe such that a portion of the treatment probe extending along the elongate axis of the treatment probe is presented in a sagittal image of the TRUS probe; and

rotating, with the portion of the treatment probe, an ultrasound image in response to a non-parallel angle between an elongate axis of the treatment probe and an elongate axis of the TRUS probe.

37) A method of treating a patient comprising:

providing a treatment contour overlaid on the image of the patient; and

the treatment contour is adjusted in response to a tissue structure shown in the image.

38) The method of 37), wherein a user identifies a structure of the treatment probe shown on a display to align an axis of the treatment profile with the treatment probe.

39) The method of 38), wherein the user identifies a structure of the treatment probe with an axial view of an image to align an axis of the treatment profile with a treatment probe.

40) The method of 39), wherein the image of the patient with the treatment profile overlaid thereon comprises a sagittal image, and wherein an axis of the treatment profile shown on the sagittal image has been placed on the sagittal image in response to the position of the structure of the treatment probe identified with the axial image.

41) The method of 38), wherein the structure of the treatment probe comprises one or more of an axis of the treatment probe, an elongated axis of the treatment probe, an opening in an exterior surface of the treatment probe, a marker on the treatment probe, or a central location of a cross-sectional profile of the treatment probe.

42) The method of 38), wherein the treatment probe is moved to a plurality of positions to determine a mapping of image coordinates to treatment probe coordinates.

43) The method of 38), wherein the image is rotated to align the image with an axis of the treatment contour before the image is shown on the display with the treatment contour.

44) The method of 38), wherein a reference axis of the treatment profile is shown on a display, and the treatment profile is adjusted relative to the reference axis.

45) The method of 44), wherein the reference axis corresponds to a rotational axis and a translational axis of an energy source that translates along and rotates relative to the axis.

46) The method of 44), wherein the reference axis comprises an axis of a treatment probe shown on a display.

47) The method of 46), wherein a user identifies an axis of the treatment probe shown in an image.

48) The method of 38), wherein the image comprises a series of images shown on a display.

49) The method of 38), wherein the image of the patient is provided with an imaging device, the treatment probe comprises a component of a treatment apparatus, and wherein a magnification of the treatment probe is adjustable independently of the treatment apparatus.

50) An apparatus for treating a patient, the apparatus comprising:

a display; and

a processor coupled to the display, the processor comprising instructions to:

providing a treatment contour overlaid on the image of the patient; and

51) An apparatus, the apparatus comprising:

a display; and

a processor coupled to the display, the processor comprising instructions to:

performing a method according to any of the preceding claims.

52) An apparatus for treating a patient, comprising:

an endoscope;

an elongate carrier for directing therapeutic energy to a target site;

an elongated tube; and

an elongated support member.

53) The device of 52), wherein the elongate tube has an inner diameter sized to receive the endoscope and the elongate carrier, and wherein the elongate support extends axially outside of and is connected to the elongate tube from outside of the elongate tube, and wherein the elongate support extends beyond a distal end of the elongate tube.

54) The device of 52), wherein each of the endoscope, the elongate carrier, and the elongate support are sized for insertion into a patient, and wherein the elongate carrier and endoscope are slidably disposed within the elongate tube, wherein the elongate support extends axially outside the elongate tube.

55) The apparatus of 52), further comprising a coupling attached to a distal end of the tube, the coupling comprising one or more openings that accommodate the endoscope and the carrier, the coupling configured to move with the endoscope relative to the carrier and support.

56) 55), wherein the coupling comprises an angled distal surface to cause tissue to exit the support as the tube and support are advanced along an entry path to a target site, and wherein the angled distal surface provides a field of view for the endoscope, wherein one or more of the elongated support or elongated carrier is within the field of view to make visible one or more of the elongated support or carrier with the endoscope.

57) 55), wherein a distal portion of an elongate tube attached to the coupling is configured to slide relative to the elongate support, and wherein the endoscope comprises a flexible proximal portion and a rigid distal portion connected to the coupling to advance and retract the coupling and the distal portion of the tube with the endoscope.

58) The apparatus of 57), wherein the coupling comprises a guide that guides the elongate carrier toward the target site.

59) The apparatus of 57), wherein the one or more openings are sized to allow the coupling to slide along an elongate carrier as the endoscope is advanced and retracted relative to the support.

60) The apparatus of 57), wherein the elongate tube comprises a telescoping tube having a first portion and a second portion, the first portion having a first diameter and the second portion having a second diameter, the first portion being positioned in a distal direction of the second portion, the first diameter being less than the second diameter such that the first portion fits within the second portion and is advanced and retracted with the endoscope, and wherein the second portion is secured to an exterior surface of the elongate support at a plurality of locations.

61) The apparatus of 57), wherein the rigid portion comprises a distal engagement structure on a distal end portion of the rigid distal portion of the endoscope, and the coupling comprises a corresponding structure that receives the distal engagement structure to engage the coupling with the rigid end portion of the endoscope and to advance and retract the coupling with the rigid end portion of the endoscope.

62) The apparatus of 61), wherein the distal engagement structure comprises a protrusion.

63) The apparatus of 62), wherein the corresponding structure of the coupling comprises a channel sized to receive the protrusion.

64) The apparatus of 57), wherein the rigid distal portion of the endoscope comprises a proximal portion having a proximal engagement structure that advances and retracts the endoscope and the coupling from outside the patient.

65) The apparatus of 64), the proximal engagement structure comprising a protrusion shaped to engage a physician-adjustable structure of a handpiece.

66) The apparatus of 65), wherein the physician-adjustable structure comprises a carriage coupled to a support with a pinion to advance and retract the endoscope with rotation of a knob.

67) The apparatus of 52), wherein the distal end of the endoscope, the distal end of the carrier, and the distal end of the support are arranged to position the distal end of the carrier between the distal end of the support and the distal end of the endoscope.

68) The apparatus of 52), wherein the elongate support comprises an axially extending suction channel extending to a plurality of suction ports at a plurality of axial locations for receiving tissue from the target site.

69) The apparatus of 68), wherein the elongated support comprises a rounded distal end comprising a larger maximum through dimension than a middle portion of the support having a plurality of openings to allow tissue to at least partially exit the carrier as the support is advanced.

70) The device of 69), wherein the rounded distal end comprises a spherical distal end, wherein the support is mounted on a first side of the ball so as to define an entry path for at least a portion of the elongated tube along with a second side of the ball, and to cause tissue to at least partially exit the elongated tube as the support and the tube are advanced along an entrance to a surgical site.

71) The device of 52), wherein the elongate support is welded to a proximal portion of the elongate tube at a plurality of locations to add stiffness and rigidity to the elongate tube and the elongate support.

72) The apparatus of 68), wherein a middle portion of an elongated support comprising the plurality of openings comprises a cross-sectional profile that curves inwardly toward the elongated carrier to provide clearance for the elongated carrier.

73) The apparatus of 52), further comprising:

a handpiece, wherein the elongated carrier and elongated tube extend from the handpiece for insertion into the patient.

74) The apparatus of 73), further comprising:

an arm, wherein the arm comprises a first unlocked configuration for inserting the elongate support and elongate carrier into the patient with the handpiece and a second locked configuration for treating the patient.

75) The apparatus of 74), wherein the arm comprises a plurality of arm connectors coupled to a plurality of handpiece connectors on the handpiece to control rotation and translation of the elongated carrier.

76) The apparatus of 75), wherein the plurality of arm connectors comprise a plurality of torque transmitters that rotate and translate the elongated carrier.

77) The apparatus of 75), wherein the elongate carrier comprises a proximal portion and a distal portion, the distal portion configured to direct energy to a target site, the proximal portion comprising an encoder that determines an angle of rotation of the carrier about an elongate axis of the carrier.

78) The apparatus of 77), wherein the encoder is located on a face of the elongated carrier.

79) The device of 77), wherein the elongate carrier comprises an elongate tube, wherein the encoder comprises an annular structure extending circumferentially and axially around a proximal portion of the elongate tube to attach the elongate encoder to the proximal portion of the tube.

80) 79), wherein the encoder comprises a gray encoder having a pattern extending circumferentially and axially around the elongate tube.

81) 79), further comprising a plurality of detectors distributed about the elongate tube at a plurality of fixed angular and radial positions to measure rotation of the probe, and wherein the fixed angular positions correspond to angular orientation of the probe about a probe axis.

82) The apparatus of 81), wherein the plurality of detectors comprises four photodetectors arranged along orthogonal axes to provide an absolute diagonal orientation of the elongated carrier with respect to the four photodetectors.

83) The apparatus of 77), wherein the elongated carrier and handpiece are configured to remove the elongated carrier from the handpiece.

84) The apparatus of 77), wherein the encoder comprises a reference that is angularly aligned with an energy emission axis of the probe.

85) The apparatus of 84), wherein the fiducial comprises a boundary extending in an axial direction toward an energy source on the carrier, the boundary being angularly aligned with the energy source.

86) The apparatus of any of 73) or 74), wherein one or more of the handpiece or arm includes an input to increase or decrease a power setting of the treatment energy.

87) The apparatus of 85), further comprising a therapy table comprising a plurality of coordinate reference positions and a plurality of amounts of energy, and wherein a maximum power setting input with the handpiece is limited in response to the plurality of amounts of energy for each of the plurality of coordinate reference positions.

88) The apparatus of 51), further comprising:

a processor comprising a therapy table, the therapy table comprising a plurality of coordinate reference positions and a plurality of energies, each of the plurality of coordinate reference positions comprising an axial position, an angular position, and a power setting of an energy source.

89) The apparatus of 51), further comprising:

an accessory configured to be coupled to an arm, the accessory including the elongate tube and an elongate support, wherein the accessory is configured to receive the elongate carrier and an endoscope.

90) The device of 89), wherein the accessory comprises a sterile accessory configured for single use.

91) The device of 89), wherein the accessory includes circuitry configured to provide a unique identification to identify the accessory among a plurality of accessories.

92) The apparatus of 91), further comprising:

a processor including instructions to limit use of the accessory to a single use.

93) The device of 92), wherein the processor includes instructions to generate a therapy table, and wherein the circuitry of the accessory includes non-volatile memory and instructions to store a therapy table in the non-volatile memory.

94) The device of 93), wherein the circuitry of the accessory includes instructions to store one or more of a power setting of the energy source, a pressure of the energy source, or a flow rate of the energy source.

95) The apparatus of 92), wherein the accessory comprises a connector that is electrically coupled to the arm and that communicates data from the circuit to the arm and from the circuit to the arm.

96) The apparatus of 89), wherein the attachment comprises a linkage that moves an energy source on the elongated carrier to a plurality of axial and angular positions, and wherein the attachment comprises a plurality of rotatable connectors that receive rotational movement from a plurality of connectors on an arm, the attachment comprising a plurality of encoders that measure the plurality of axial and angular positions, the attachment comprising a connector that transmits signals from the plurality of encoders to an arm, and wherein a processor off the attachment coupled to the connector receives the signals and rotates the plurality of rotatable connectors to drive the energy source to the plurality of axial and angular positions.

97) 89), wherein the accessory comprises a handpiece shaped to be a part of a user to manipulate the accessory before locking the arm.

98) The device of 89), wherein the accessory comprises a component of a kit configured to treat a target organ.

99) The apparatus of 89), wherein the arm comprises one or more of a manually movable arm or a robotic arm.

100) A method comprising providing the apparatus according to any one of the preceding claims.

Incorporation by reference

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

Drawings

The novel features believed characteristic of the invention are set forth in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

FIG. 1 is a schematic view of a device suitable for performing an intraurethral debulking of prostate tissue, in accordance with an embodiment;

figures 2A-2D illustrate the use of the device of figure 1 in performing a prostate tissue debulking procedure;

fig. 3A and 3B illustrate a system to treat a patient according to an embodiment;

FIG. 4A illustrates surgical site pressure adjustment with substantially constant pressure and variable flow, according to an embodiment;

FIG. 4B illustrates surgical site flow regulation with a pump providing substantially fixed fluid flow and substantially constant pressure, according to an embodiment;

FIG. 5A illustrates an organ suitable for incorporation according to many embodiments;

FIG. 5B shows the prostate gland of FIG. 5A treated with an apparatus according to many embodiments;

fig. 6A shows an ablation flame visible to the human eye, in accordance with an embodiment;

FIG. 6B shows a high-speed image of the ablation flame as in FIG. 6A;

fig. 7 illustrates a plurality of shedding pulses and a scanning ablation jet to provide smooth and controlled tissue erosion over a plurality of overlapping locations, in accordance with an embodiment;

FIG. 8A illustrates an accessory device according to an embodiment;

FIG. 8B shows components of the accessory device;

FIG. 8C illustrates components of an accessory device having a coupling in a partially retracted position and an elongated carrier including an energy source extending through the coupling toward a distal end of the elongated support;

FIG. 8D shows a distal portion of the elongate support and the elongate tube with a coupling mounted thereon;

8E 1-8E 4 illustrate couplings according to embodiments;

FIG. 8F illustrates a bottom view of a bracket according to an embodiment;

fig. 8G shows an end view of a bracket according to an embodiment;

FIG. 8H illustrates an isolated endoscope in accordance with an embodiment;

fig. 8I1 shows a side view of an endoscope according to an embodiment;

FIG. 8I2 shows a side view along section AA as shown in FIG. 8I 1;

FIG. 8I3 shows section BB of the endoscope of FIG. 8I 1;

FIG. 8I4 shows a top view of the endoscope as in FIG. 8I 1;

FIG. 8I5 shows the distal end of the endoscope as in FIG. 8I 1;

FIG. 8J illustrates a housing of a cradle as described herein;

FIG. 8K illustrates an end view of an accessory device as described herein;

FIG. 8L illustrates a component configured to couple to an arm of an accessory device;

fig. 8M illustrates a view of a top side of an accessory device, according to an embodiment;

fig. 8N shows components of an arm according to an embodiment;

FIGS. 8O1 and 8O2 illustrate the internal structure of the arm member shown in FIG. 8N;

FIG. 8P illustrates a link of an accessory device according to an embodiment;

FIG. 8Q shows the encoder mounted on the proximal end of the carriage;

fig. 8R1 shows an encoder according to an embodiment;

FIG. 8R2 shows a table showing coordinate references for different turns measured using multiple photodetectors;

fig. 8S shows a suction port on the distal end of the support according to an embodiment;

FIG. 8T illustrates a console according to an embodiment;

figures 9A and 9B illustrate side and top views, respectively, of a treatment probe shaft aligned with a sagittal plane of an imaging probe, according to an embodiment;

figures 9C and 9D illustrate side and top views, respectively, of a treatment probe traversing a sagittal image plane field of view, according to an embodiment;

10A-10T illustrate a treatment screen of a device according to an embodiment;

fig. 11 shows a method of treating a patient according to an embodiment;

FIG. 12 illustrates maximum tissue penetration depth of a cut versus flow rate through a nozzle, according to an embodiment;

fig. 13 illustrates selective removal of potatoes as a selective tissue removal model, wherein porcine blood vessels are positioned over the cuts of the potatoes, under an embodiment; and

FIG. 14 shows potatoes processed with a predetermined treatment profile and treatment table based on user input, according to an embodiment.

Detailed Description

The embodiments disclosed herein can be combined in a number of ways to provide improved treatment to a patient. Although reference is made to some components in some figures and other components in other figures, it is contemplated that each of these components may be combined with any one or more of the other components to provide improved treatment to the patient.

As used herein, the terms proximal and distal in the context of a device refer to proximal and distal as referenced to a device located outside of a patient, such that proximal may refer to a component located outside of the patient and distal may refer to a component located inside of the patient.

As used herein, similar words and characters denote similar structures.

As used herein, the terms carrier probe and treatment probe are used interchangeably.

Is incorporated by reference

The subject matter and corresponding text of fig. 1-2D described in the following documents have been incorporated by reference: U.S. application publication No. US 20110184391 entitled "MULTI FLUID device reset METHODS AND DEVICES", serial No. 12/700,568 filed on 2/4/2010, attorney docket No. 41502-703.501; and PCT application PCT/US2011/023781 entitled "MULTI FLUID device reset METHODS AND DEVICES" filed on WO2011097505 published on 2/4/2011 and 8/4/2007; the entire disclosures of the above documents have been previously incorporated by reference herein.

Referring to fig. 1, an exemplary prostate tissue debulking device 10 constructed in accordance with the principles of the present invention includes a catheter assembly generally comprising a shaft 12 having a distal end 14 and a proximal end 16. The shaft 12 is typically a polymer extrusion that includes 1, 2, 3, 4 or more axial lumens extending from the hub 18 at the proximal end 16 to a location near the distal end 14. The shaft 12 will typically have a length ranging from 15cm to 25cm and a diameter ranging from 1mm to 10mm, typically from 2mm to 6 mm. As will be described in more detail below, the shaft will have sufficient column strength so that it can be introduced up through the male urethra.

The shaft will include an energy source positioned in the energy delivery region 20, where the energy source can be any of a variety of specific components as discussed in more detail below. Distal to the energy delivery region, the inflatable anchor balloon 24 will be positioned at the distal end 14 of the shaft or very close to the distal end 14. The balloon will be connected through one of the axial lumens to a balloon inflation source 26 connected through the liner 18. In addition to the energy source 22 and balloon inflation source 26, the hub will optionally also include a source for irrigation/irrigation 28, suction 30 and/or air jet (pressurized CO)₂Or other gas) source 32. In an exemplary embodiment, the irrigation or irrigation source 28 may be connected through an axial lumen (not shown) to one or more delivery ports 34 proximal of the balloon anchor 24 and distal of the energy delivery region 20. The suction source 30 may be connected to a second port or opening 36 that is generally located proximal to the energy delivery region 20, while the jet source 32 may be connected to an additional port 38 that is also generally located proximal to the energy delivery region. It should be understood that while certain locations may result in certain advantages described herein, the location of

ports

34, 36, and 38 is not critical, and it should be appreciated that the lumens and delivery devices may be provided by additional catheters, tubes, etcSuch additional conduits, etc. are provided, for example, as including a coaxial sleeve, sheath, etc. positionable over the shaft 12.

Although the present embodiment is described with reference to a human prostate, it should be understood that it can be used generally for treating a mammalian prostate. Referring now to fig. 2A-2D, a prostate tissue debulking device 10 is introduced through the male urethra U to a region within the prostate gland P located proximate to the distal end of the bladder B. The anatomy is shown in fig. 2A. Once the catheter 10 has been positioned such that the anchoring balloon 24 is located immediately at the distal end of the bladder neck BN (fig. 2B), the balloon may be inflated, preferably occupying substantially the entire interior of the bladder, as shown in fig. 2C. Once the anchoring balloon 24 is inflated, the position of the prostate tissue reduction device 10 will be fixed and stabilized within the urethra U to position the energy delivery region 20 within the prostate P. It should be appreciated that proper positioning of the energy delivery region 20 is solely dependent upon inflation of the anchoring balloon 24 within the bladder. Since the prostate is located immediately proximal to the bladder neck BN, the delivery region can be properly positioned by spacing the distal ends of the energy delivery regions very close to the proximal end of the balloon, typically at a spacing in the range from 0mm to 5mm, preferably from 1mm to 3 mm. As shown by the arrows in fig. 2, energy may be delivered into the prostate for debulking after the anchor balloon 24 has been inflated. As shown in fig. 2D, once the energy has been delivered over the desired surface area for a period of time, the energy region can be stopped and the prostate will be debulked to relieve the pressure on the urethra. At this point, as shown in fig. 2D, irrigation fluid may be delivered through port 34 and aspirated into port 36. Optionally, after treatment, the area may be cauterized using a cauterization balloon and/or stent which may be placed using a modified or separate catheter device.

Fig. 3A and 3B illustrate a system to treat a patient, according to an embodiment. The system 400 includes a treatment probe 450 and optionally an imaging probe 460. The treatment probe 450 is coupled to the console 420 and the linkage 430. The imaging probe 460 is coupled to an imaging console 490. The patient treatment probe 450 and the imaging probe 460 may be coupled to a common base 440. The patient is supported by patient support 449. The treatment probe 450 is coupled to the base 440 with an arm 442. The imaging probe 460 is coupled to the base 440 with an arm 444.

The patient is placed on the patient support 449 so that the treatment probe 450 and the ultrasound probe 460 can be inserted into the patient. The patient may be placed in one or more of a number of positions, such as, for example, a prone position, a supine position, an upright position, or an inclined position. In many embodiments, the patient is placed in the lithotomy position, and a foot stirrup may be used, for example. In many embodiments, the treatment probe 450 is inserted into the patient in a first orientation on a first side of the patient and the imaging probe is inserted into the patient in a second orientation on a second side of the patient. For example, the treatment probe may be inserted into the patient's urethra from the front side of the patient, and the imaging probe may be inserted into the patient's intestine from the back side of the patient through the rectum. The treatment probe and the imaging probe may be positioned within the patient with one or more of urethral tissue, urethral wall tissue, prostate tissue, intestinal tissue, or intestinal wall tissue extending therebetween.

The treatment probe 450 and the imaging probe 460 can be inserted into the patient in one or more of a number of ways. During insertion, each arm may include a substantially unlocked configuration to enable desired rotation and translation of the probe to insert the probe into the patient. The arm may be locked when the probe has been inserted to the desired location. In the locked configuration, the probes can be oriented relative to each other in one or more of a number of ways, such as parallel, oblique, horizontal, oblique, or non-parallel, for example. It may be helpful to determine the orientation of the probe using an angle sensor as described herein to map the image data of the imaging probe to the treatment probe coordinate reference. Mapping tissue image data to the treatment probe coordinate reference space may allow for accurate targeting and treatment of tissue identified for treatment by an operator, such as a physician.

In many embodiments, the treatment probe 450 is coupled to the imaging probe 460. To match therapy to the probe 450 based on images from the imaging probe 460. The coupling may be accomplished with a common base 440 as shown. Alternatively or in combination, the treatment probe and/or imaging probe may include a magnet to keep the probes aligned while passing through the patient's tissue. In many embodiments, the arm 442 is a movable and lockable arm such that the treatment probe 450 can be positioned at a desired location within the patient. When the probe 450 has been positioned on the desired location on the patient, the arm 442 may be locked with the arm lock 427. The imaging probe may be coupled to the base 440 with an arm 444, which may be used to adjust the alignment of the probe when the treatment probe is locked in place. The arm 444 may, for example, comprise a lockable and movable probe under the control of an imaging system or console and user interface. The movable arm 444 may be micro-actuatable such that the imaging probe 440 can be adjusted relative to the treatment probe 450 with a small movement (e.g., on the order of 1 millimeter).

In many embodiments, the treatment probe 450 and the imaging probe 460 are coupled to an angle sensor to enable control of treatment based on the alignment of the imaging probe 460 with the treatment probe 450. The angle sensor 495 is coupled to the treatment probe 450 with a support 438. The angle sensor 497 is coupled to the imaging probe 460. The angle sensor may comprise one or more of many types of angle sensors. For example, the angle sensor may include an goniometer, an accelerometer, and combinations thereof. In many embodiments, the angle sensor 495 comprises a 3-dimensional accelerometer to determine the three-dimensional orientation of the treatment probe 450. In many embodiments, the angle sensor 497 includes a 3-dimensional accelerometer to determine the three-dimensional orientation of the imaging probe 460. Alternatively or in combination, the angle sensor 495 can include an goniometer to determine the angle of the treatment probe 450 along the elongate axis of the treatment probe. The angle sensor 497 may comprise an goniometer to determine the angle of the imaging probe 460 along the elongate axis of the imaging probe 460. The angle sensor 495 is coupled to the controller 424. The imaging probe's angle sensor 497 is coupled to the processor 492 of the imaging system 490. Alternatively, angle sensor 497 may be coupled to controller 424 and may also be combined.

The console 420 includes a display 425, the display 425 being coupled to the processor system in the components to control the treatment probe 450. The console 420 includes a processor 423 with a memory 421. The communication circuit 422 is coupled to the processor 423 and the controller 422. The communication circuit 422 is coupled to an imaging system 490. Console 420 includes an assembly of endoscope 35 coupled to anchor 24. The irrigation control 28 is coupled to the probe 450 to control irrigation and irrigation. A suction control 30 is coupled to the probe 450 to control suction. The endoscope 426 may be a component of the console 420 and may be an endoscope that is insertable with the probe 450 to treat a patient. An arm lock 427 of the console 420 is coupled to the arm 422 to lock the arm 422 or allow the arm 422 to move freely to insert the probe 450 into the patient.

The console 420 may include a pump 419, the pump 419 being coupled to the carrier and the nozzle as described herein.

The processor, controller, and control electronics and circuitry may include one or more of a number of suitable components, such as one or more processors, one or more Field Programmable Gate Arrays (FPGAs), and one or more memory storage devices. In many embodiments, the control electronics control a control panel of a graphical user interface (hereinafter "GUI") to provide preoperative planning in accordance with user-specified treatment parameters, as well as to provide user control of the surgical procedure.

The treatment probe 450 includes an anchor 24. The anchor 24 anchors the distal end of the probe 450 while the probe 450 is delivering energy to the energy delivery region 20. The probe 450 may include a nozzle 200 as described herein. The probe 450 is coupled to the arm 422 using a linkage 430.

Linkage 430 includes components to move energy delivery region 20 to a desired target location of the patient, e.g., based on an image of the patient. The linkage 430 includes a first portion 432 and a second portion 434 and a third portion 436. The first portion 432 includes a substantially fixed anchoring portion. The substantially fixed anchor portion 432 is fixed to a support 438. The support 438 may comprise a frame of reference for the linkage 430. The support 438 may comprise a rigid frame or housing to rigidly and securely couple the arm 442 to the treatment probe 450. First portion 432 remains substantially stationary while second portion 434 and third portion 436 move to direct energy from probe 450 to the patient. The first portion 432 is fixed to a substantially constant distance 437 from the anchor 24. The substantially fixed distance 437 between the anchor 24 and the fixed first portion 432 of the linkage allows for accurate placement of the treatment. The first portion 424 can include a linear actuator to accurately position the high pressure nozzle at a desired axial location along the elongate axis of the probe 450 in the treatment region 20.

The elongate axis of the probe 450 generally extends between a proximal portion of the probe 450 near the linkage 430 and a distal end having an anchor 24 attached thereto. The third portion 436 controls the angle of rotation about the elongate axis. During treatment of the patient, the distance 439 between the treatment region 20 and the fixed portion of the linkage changes with reference to the anchor 24. The distance 439 is adjusted in response to computer control to set the target location of the reference anchor 24 along the elongate axis of the treatment probe. The first portion of the linkage remains stationary while the second portion 434 adjusts the position of the treatment area along the axis. The third portion 436 of the linkage adjusts the angle about the axis in response to the controller 424 to enable very accurate control of the distance along the axis at the angle of treatment with reference to the anchor 24. The probe 450 may include a rigid member, such as a spine, extending between the support 438 and the anchor 24 such that the distance from the linkage 430 to the anchor 24 remains substantially constant during treatment. The treatment probe 450 is coupled to a treatment assembly as described herein to allow treatment with one or more forms of energy, such as mechanical energy from a jet, electrical energy from electrodes, or optical energy from a light source such as a laser source. The light source may comprise infrared, visible or ultraviolet light. The energy delivery region 20 is movable under the control of the linkage 430 to deliver a desired form of energy to the target tissue of the patient.

Imaging system 490 includes memory 493, communication circuitry 494 and processor 492. The processor 492 in the corresponding circuitry is coupled to the imaging probe 460. An arm controller 491 is coupled to the arm 444 to accurately position the imaging probe 460.

Fig. 4A illustrates pressure adjustment of a surgical site with substantially constant pressure and variable flow. The saline bag is placed at a height to provide a substantially constant pressure adjustment. The saline bag may be placed at a height corresponding to about 50 to 100mm of mercury (hereinafter, referred to as "mmHg"). The saline bag is coupled to an irrigation port described herein. The collection bag is coupled to one or more of the irrigation ports, aspiration ports, or aspiration ports described herein. The collection bag collects the tissue removed with the waterjet ablation probe 450 described herein.

Fig. 4B illustrates flow fluid regulation of a surgical site with a pump providing a substantially fixed fluid flow. The pump removes fluid from the surgical site at a substantially fixed flow rate. For example, the pump may comprise a peristaltic pump. The pump is configured to substantially cooperate with the aeration^TMThe saline flow rate removes fluid at the same rate or at a greater rate to inhibit pressure buildup at the surgical site. For example, a peristaltic pump may be coupled to the suction port of the manifold including the tissue removal port 456C as described herein. Improved aspiration is provided by providing a pump having a flow rate that is at least the flow rate of the tissue ablation jet because ablated tissue that might otherwise occlude the tissue removal opening and channel can be subjected to greater pressure while the pump maintains a substantially fixed flow rate, thereby removing material that would otherwise occlude the channel.

The irrigation flow from the saline bag may remain open to provide at least two functions: 1) maintaining pressure based on the height of the saline bag; and 2) providing a safety check valve to allow a person to visually see the pink stream entering the bag in the event that the peristaltic pump is not functioning properly.

In an alternative embodiment, the flow of the pump includes a variable rate to provide a substantially constant pressure within the patient proximate the surgical site. Active sensing of the pressure of the organ being treated and the variable flow rate of the pump may include a closed loop pressure regulation system. The pump may be coupled to a sensor, such as a pressure sensor, and the flow rate varied to maintain a substantially constant pressure. The pressure sensor may be located in one or more of a number of locations, such as on the treatment probe, within an aspiration channel of the probe, in a recess in an outer surface of the probe, on an inner surface of the probe coupled to the surgical site, or near an inlet to a pump on a console, for example.

Fig. 5A shows an organ suitable for incorporation according to an embodiment. The organ may comprise one or more of the many organs described herein, for example, the prostate. In many embodiments, the organ includes, for example, the envelope and the tissue contained within the envelope, as well as the enveloped blood vessels and nerves located on the exterior of the envelope. In many embodiments, the organ comprises a prostate gland. For example, the prostate may include hyperplasia, such as benign prostatic hyperplasia, or cancer, and combinations thereof. In many embodiments, the hyperplastic tissue can include tissue located within a patient that may not have been detected to have cancer. In many embodiments, the enveloped blood vessels and nerves extend along the outer surface of the prostate. In many embodiments, the hyperplastic tissue may be located up on the prostate gland. In many embodiments, the hyperplastic tissue may include tissue of unknown specificity with respect to whether the tissue comprises cancerous or benign tissue.

Fig. 5B shows the prostate of fig. 5A treated with a device according to an embodiment. In many embodiments, the tissue of the prostate is removed according to a tissue removal profile. The tissue removal profile may, for example, comprise a predetermined tissue removal profile that guides tissue removal based on the images described herein. Alternatively, the tissue removal profile may comprise a removal profile of tissue removed with a handheld tissue removal device. In many embodiments, tissue of an organ, such as the prostate, is removed down into the envelope, for example, to reduce the distance from the tissue removal profile to the outside of the envelope.

The apparatus for tissue removal may include a nozzle configured to deliver a fluid stream, wherein the fluid stream may include one or more of a liquid or a gas. The liquid fluid stream may, for example, comprise one or more of water or saline. The liquid fluid stream can be configured to exit the nozzle in the form of a liquid ablation jet to cause cavitation in the prostate tissue and to dissociate the tissue into a plurality of fragments. The liquid fluid stream may be released into the liquid in which the nozzle is immersed to provide cavitation with a de-pulsing as described herein. The liquid in which the nozzle is immersed may for example comprise one or more of water or saline.

Fig. 6A illustrates an ablation flame visible to the human eye, in accordance with an embodiment.

Fig. 6B shows a high-speed image of an ablation flame as in fig. 6A. The image was taken at a speed of about 1/400 seconds.

The data of fig. 6A and 6B indicate that the ablation flame includes a plurality of white air masses generated with the ablation stream when released from the nozzle. Studies related to the embodiments show that cavitation pockets can be detached from the jet at characteristic detachment frequencies. The length 992 of each air mass is related to the shedding frequency and velocity of the air mass. The relatively cool ablation flame of the jet includes a length 990 corresponding to the cutting length of the jet, which may be adjusted as described herein to cut tissue to a controlled depth. In many embodiments, in a non-cutting configuration as shown in fig. 6B, the nozzle of the jet is positioned at least about one-quarter of the length 992 of the shedding clouds to allow the shedding clouds to form substantially before the air clouds impact the tissue. Such divergence of the shedding clouds to a larger cross-sectional size may also provide improved tissue removal, as the air clouds may be distributed to a larger tissue area, and such divergence may provide improved overlap between pulses of the jets.

In addition to the impact pressure of the jet, the highly turbulent and turbulent regions corresponding to the white air mass of the image contribute significantly to tissue ablation as described herein. The white air mass includes a plurality of cavitation regions. When pressurized water is injected into the water, small cavitations are generated in the low pressure region within the shear layer near the nozzle outlet. The small cavitations may include cavitation vortices. The cavitation vortices merge into each other to form large, non-continuous cavitation structures that appear as cavitation pockets of air in the high-speed image. These cavitation boluses provide effective ablation when interacting with tissue. Without being bound to any particular theory, it is believed that the cavitation bolus of air impinging on the tissue, in combination with the high velocity fluid that defines cavitation of the impinging tissue, results in a substantial erosion of the tissue associated with cavitation.

The nozzle and pressure as described herein may be configured to provide a pulsed air mass, for example, by control of the nozzle angle by one of ordinary skill in the art based on the teachings provided herein. In many embodiments, the nozzle of the fluid delivery element includes a cavitation jet to improve ablation of tissue.

The fluid delivery element nozzle and pressure may be arranged to provide a shedding frequency suitable for removing tissue.

In many embodiments, the "white mass" of "flame" includes an "entrainment" region around which water is drawn into or "entrained" into the jet. Studies related to the embodiments indicate that entrainment of fluid may be related to shedding frequency.

According to embodiments, the shedding frequency and size of the bolus of air that is shed from the jet can be used to provide tissue ablation. The shedding frequency may be combined with the angular scan rate of the probe about the longitudinal axis to provide an overlap of the locations where each bolus interacts with the tissue.

Fig. 7 illustrates a plurality of shedding pulses 995 and a scan of the ablation jet to provide smooth and controlled tissue erosion over a plurality of overlapping locations 997, in accordance with an embodiment. When a pump is employed, this shedding frequency may be significantly higher than the frequency of the pump, thereby providing multiple shedding clouds for each pulse of the pulsatile pump. The scan rate of the probe may be related to the shedding frequency to provide improved tissue removal, for example with shedding boluses configured to provide overlapping pulses.

In many embodiments, the system includes a pump having a frequency less than the frequency of the shedding pulses to provide a plurality of shedding pulses for each pulse of the pump. The pump may have a pulse rate of at least about 50Hz, such as a pulse rate in the range from about 50Hz to about 200Hz, and the de-pulsing comprises a frequency of at least about 500Hz, such as a frequency in the range from about 1kHz to about 10 kHz.

Although pulsing of the pump is illustrated, a continuous flow pump may also be utilized to provide a similar pulsed bolus scan.

While the nozzle can be configured in one or more of a number of ways, in many embodiments the nozzle includes a Strouhal number (hereinafter "St") in a range from about 0.02 to about 0.3, such as a Strouhal number in a range from about 0.10 to about 0.25, and in many embodiments a Strouhal number in a range from about 0.14 to about 0.2.

In many embodiments, the strouhal number is defined as:

St＝(Fshed)*(W)/U

where Fshed is the shedding frequency, W is the width of the cavitation jet, and U is the jet velocity at the outlet. One of ordinary skill in the art can modify a nozzle as described herein to obtain a shedding frequency suitable for incorporation according to embodiments described herein, and can perform experiments to determine the bolus length and shedding frequency suitable for tissue removal.

A nozzle configuration providing a plurality of shedding clouds is suitable for use with one or more of the probes described herein.

Fig. 8A illustrates an accessory device 800 according to an embodiment. The accessory device is configured to attach to an arm as described herein. The accessory device includes one or more components of a surgical system for treating a patient as described herein. In many embodiments, the accessory device includes a handpiece 802 for enabling a surgeon to manipulate the accessory device with the arm in an unlocked position to insert the distal end of the accessory device into the patient. In many embodiments, the accessory device includes a linkage 804 that includes a rotatable body configured to receive rotational torque from an arm as described herein.

For example, the accessory device includes a plurality of components sized to fit within a surgical access site (such as a urethra) of a patient. The accessory device includes an elongated support 806, an elongated tube 808, and a coupling 814, for example, as described herein. The elongated support 806 comprises a rigid support configured to be inserted into a patient. The elongated support may include a rounded distal end to facilitate insertion into the patient along the access path to expand the path to allow and facilitate insertion of the coupling. The elongated support may include a plurality of suction channels positioned to remove excised tissue from the surgical site. The elongate support may include a plurality of channels extending from the suction port 828 to an opening on the distal end of the elongate support.

The elongate tube 808 can comprise a telescoping tube that includes a first distal portion 810 and a second proximal portion 812. The second portion may be sized larger than the first portion to accommodate the first portion and allow sliding of the tube. A coupling 814 on the distal end of the distal portion of the tube may be connected to the endoscope. An endoscope connected to the coupling may be movable proximally and distally, and the elongate tube may be shortened and reduced in length as the coupling moves proximally and distally with the distal end 818 of the endoscope.

The coupling 814 can include a sloped distal surface 820 or at least one surface shaped to facilitate insertion of the coupling into a patient. The coupling may be positioned adjacent the distal end of the elongated support when the accessory device is inserted into the patient. The endoscope tip 818 may be coupled to the coupling using a coupling structure. For example, the coupling may include an engagement structure that is shaped to receive a corresponding engagement structure on the endoscope tip, such that the coupling mates with and is effectively keyed and locked to the endoscope tip. Proximal and distal movement of the endoscope may move the coupling proximally and distally in response to a corresponding decrease or increase in length of the elongate tube.

The accessory device can include a hub 822 including an irrigation port 824 and an aspiration port 826. The irrigation port may be coupled to the inner channel of the elongate tube to direct fluid, such as saline, to an irrigation opening 816 located on the distal end of the elongate tube. The irrigation opening may provide fluid, such as saline, to the surgical site. Alternatively, a jet of gas may be used to provide a fluid, such as a gas, to the surgical site. The suction ports on the liner may be connected to openings on the elongate support by means of channels extending axially along the elongate support.

Elongate tube 808 of the endoscope includes a first distal portion 810 of the tube and a second proximal portion 812 of the elongate telescoping tube. The second proximal portion can be sized larger than the first distal portion to slidably receive the first distal portion to allow the coupling to move proximally and distally with the endoscope.

The accessory device includes a plurality of structures that allow a user (such as a physician) to adjust the endoscope independently of other components of the device. In many embodiments, the endoscope is coupled to an endoscope bracket 828. The endoscope bracket can be advanced and retracted to move a distal end of an endoscope connected to the coupling proximally and distally. The accessory device can include a bracket 830 coupled to a pinion that allows the endoscope carrier to move proximally and distally as a knob 832 on the endoscope carrier is rotated. For example, the accessory device can include a track 834 that engages the endoscope bracket such that the endoscope bracket can slide along the track as the knob is rotated. In many embodiments, the accessory device includes a connection of a high voltage cable 836 to a carrier that carries the therapeutic energy source under control of the linkage.

Fig. 8B shows the components of the accessory device 800. The endoscope may include a rigid distal portion 838 and a flexible proximal portion 840. The rigid portion of the endoscope can extend from the endoscope holder 828 to the distal tip of the endoscope. The rigid portion of the endoscope may extend through a seal 842 to seal and contain fluid from the surgical site. The rigid portion of the endoscope can be coupled to the carriage using an engagement structure on the proximal portion of the endoscope. The rigid portion of the endoscope can also be coupled to the coupling with a distal engagement structure located near the tip of the endoscope. A rigid portion of the endoscope extending between the carriage and the coupling provides for proximal and distal movement of the distal portion of the telescoping tube and the coupling.

In many embodiments, a flexible high pressure brine tube 836 extends to the accessory device to provide pressurized fluid from the external pump.

In many embodiments, the accessory device is configured to enable a user to remove a device component, such as an endoscope. For example, a carriage release 844 may be provided on the proximal end of the accessory device that allows a user to slide the carriage proximally off the track to remove the endoscope from the surgical site.

Fig. 8C illustrates components of the accessory device 800 having the coupling 814 in a partially retracted position and the elongate carrier 846 including the energy source 848 extending through the coupling toward the distal end of the elongate support 806. In many embodiments, the endoscope tip can be at least partially retracted to view the treatment probe 846 in the support. An elongate carrier including a treatment probe may have an energy source thereon to direct energy to a treatment site. The distal portion of the elongated tube 808 may be retracted within the proximal portion of the elongated tube to allow the coupling to which the endoscope tip is attached to view the treatment site. For example, the coupling may retract proximally as the knob is rotated to a proximal position.

Elongate support 806 may be connected to elongate tube 808 in one or more of a number of ways to add stiffness. For example, the elongate support may be welded to the proximal portion of the elongate tube at a plurality of locations 850 to add stiffness to the combination of the elongate support and the elongate tube.

The welded portion of the elongate tube may remain in a fixed position relative to the elongate support as the distal portion of the elongate tube slides relative to the proximal fixed portion of the tube.

Fig. 8D shows a distal portion of elongate support 806 and elongate tube 808 with coupling 814 mounted thereon. The elongate support may include a reduced-pressure tip (such as a rounded distal tip 852) to facilitate insertion along a surgical access path (such as through the urethra). The sloped distal surface 820 of the coupling can facilitate insertion and urge tissue away from the elongate support. In many embodiments, the elongated support includes a recess sized to receive a portion of the coupling such that a distal most tip of the coupling fits within the recess behind the reduced pressure distal tip. The reduced-pressure distal tip may define an access path for the accessory device into the patient, and the angled distal surface of the coupling may follow the reduced-pressure tip, and the tip of the coupling may follow the path of the reduced-pressure tip. This combination of reduced pressure tip and angled distal surface may facilitate insertion.

Elongate tube 808 including a plurality of openings 816 can move with coupling 814. The coupling that receives the distal tip of the endoscope can be configured in one or more of a number of ways to receive the endoscope tip, such as with a channel or slot that receives a protrusion on the endoscope and locks to the endoscope. The distal portion of the elongate telescoping tube can include an opening 854 that receives a fastener from the coupling. A fastener extending from the coupling through the opening of the tube may effectively lock the coupling to the distal end of the tube. The distal end 810 of the tube may include a plurality of irrigation openings 816. The plurality of irrigation openings may be movable with the endoscope tip to irrigate and facilitate viewing of the endoscope tip. The movement of the irrigation opening typically directs fluid toward the surgical site so that the fluid may be directed. For example, when the treatment probe tip is submerged in liquid, the irrigation openings that move with the endoscope tip have the advantage of flushing the tip and providing fluid to increase visibility.

Fig. 8E 1-8E 4 illustrate a coupling 814 according to an embodiment. Fig. 8E1 shows a cross-sectional end view. Fig. 8E2 shows a cross-sectional side view. Fig. 8E3 shows a side view and 8E4 shows an end view. The coupling includes a carrier channel 856 to accommodate the treatment probe on the carrier as described herein. The carrier channel is sized to allow the carrier including the treatment probe to slide proximally, distally, and rotationally without interference from the coupling. The carrier channel may include guides that facilitate alignment and placement and stabilize the position of the distal end of the carrier including the energy source. The coupling includes an endoscope channel 858 sized to receive an endoscope. The endoscope channel can be configured to receive an endoscope and an engagement structure of the endoscope and lock the engagement structure of the endoscope to the coupling.

With the side view shown in fig. 8E2, the field of view 860 of the endoscope is shown. The field of view of the endoscope may be that of a commercially available endoscope, such as a 70 ° field of view, for example. The endoscope can view the surgical site, the elongate support, and the treatment probe of the carrier from within the endoscope channel. In many embodiments, the angled surface 820 of the distal end of the coupling is angled to define a field of view along an upper portion of the endoscope's field of view.

As shown in fig. 8E3, the coupling 814 can include a slot 862 that receives a protrusion on the endoscope. For example, the slot may be sized to allow the protrusion to enter the slot as the endoscope is rotated. Although the slot is not shown, the engagement structure of the coupling that receives the engagement structure on the distal end of the rigid portion of the endoscope may be configured in many ways, such as with one or more of a locking structure, a threaded structure, a bushing, and threads, for example.

For example, the endoscope tip may include a leaf spring or similar structure configured to snap into a corresponding engagement edge or lip disposed along at least a portion of the inner circumference of the coupling. By using this mechanism, the user can lock the endoscope tip to the coupling by simply pushing the endoscope tip into the coupling until the leaf spring engages the engagement edge. To allow the endoscopic tip to be detached from the coupling, a portion of the inner circumference of the coupling may include a beveled edge configured to allow the leaf spring to slide out. To detach the endoscope tip from the coupling, the user can rotate the endoscope until the leaf spring is aligned with the beveled edge and pull the endoscope out.

Also shown in fig. 8E3 is a protrusion 855 extending through the tube.

Fig. 8E4 shows the approximate dimensions of treatment probe carrier 846 and endoscope 866, shown in phantom in carrier channel 856 and endoscope channel 858, respectively. The carrier channel and endoscope channel may be sized and spaced to provide a gap (clearance gap)868 between the carrier and endoscope. In many embodiments, the rigid distal tip of the endoscope includes a protrusion 864 as described herein. The protrusion may extend a radial distance from the rigid distal portion to fit in the slot 862 and engage the coupling. In many embodiments, the protrusion can be sized to extend a longer distance than the gap to lock the coupling to the endoscope when a carrier probe including an energy source extends through the carrier channel. For example, this configuration can facilitate assembly and disassembly of the coupling from the endoscope with the carrier removed, and provide locking of the coupling with the carrier inserted therein.

Fig. 8F shows a bottom view of a bracket 828 according to an embodiment. The bottom view shows the rigid portion 838 of the endoscope coupled to the proximal engagement structure 870 of the endoscope and the flexible portion 840 of the endoscope. The proximal engagement structure of the endoscope fits within the engagement structure 872 of the carriage such that proximal and distal movement of the carriage moves the rigid portion of the endoscope in the engagement structure. The bottom view of the bracket shows the pinion gear 874 rotating with the knob 832. The pinion engages the carrier as described herein. Also shown in the bottom view are slots 876 on each side of the carriage that receive the rails of the accessory device as described herein. The engagement structure 872 of the bracket can include a plurality of protrusions. For example, the plurality of protrusions may extend on a proximal side of the bracket and a distal side of the bracket to move the endoscope proximally and distally.

Fig. 8G shows an end view of a bracket 828 according to an embodiment. The carriage includes a plurality of slots 876 sized to receive the rails of the accessory device. The cradle also includes a channel 878 sized to receive an endoscope.

The brackets shown in fig. 8F and 8G may be configured to have a low profile to facilitate user operation of the accessory device. For example, the bracket may be configured as a housing having a relatively short height, and the knob may be shaped and sized to have a relatively small diameter and a long length (e.g., to facilitate gripping of the knob by a user).

Fig. 8H shows endoscope 866 in isolation, in accordance with an embodiment. The endoscope includes an eyepiece 880 that allows a user (such as a surgeon) to view a surgical site from a distal end of the endoscope, where the eyepiece is located on a proximal end of the endoscope. The endoscope includes an illumination port 882 that allows a camera (such as a high-definition camera) to be coupled to the endoscope. The endoscope includes a proximal flexible portion 840 as described herein. The endoscope includes a proximal engagement structure 870. The proximal engagement structure is positioned between the flexible proximal portion 838 of the endoscope and the rigid distal portion 840 of the endoscope. The endoscope includes a distal engagement structure 884 as described herein.

Fig. 8I1 shows a side view of endoscope 866. Fig. 8I2 shows a side view along section AA as in fig. 8I 1. Fig. 8I3 shows section BB of the endoscope of fig. 8I1, where section BB includes structures similar to those shown in section AA. Fig. 8I4 shows a top view of the endoscope as in fig. 8I 1. Fig. 8I5 shows the distal end of an endoscope as in fig. 8I 1. The endoscope includes an eyepiece 880, an illumination port 882, a flexible portion 840, a proximal engagement structure 870, and a rigid distal portion 838 and a distal end 818 of the endoscope, as described herein. Fig. 8I2 and 8I3 illustrate cross-sectional views of an endoscope and structure that provides fixed alignment of the endoscope relative to the engagement structure. For example, the flat surfaces shown along section AA and section BB correspond to the largest dimension across the proximal engagement structure. Securing alignment of the proximal engagement structure with the endoscope may facilitate alignment and ensure an accurate frame of reference when the endoscope is used. Fig. 8I4 shows distal engagement structure 884 along section G in a top view. Detail G in fig. 8I5 shows a distal engagement structure 884 extending distally with the protrusion 864.

In many embodiments, the proximal engagement structure includes a reference structure, such as a maximum through dimension, that defines an orientation of the endoscope with respect to the accessory device. The maximum through dimension proximal engagement structure will inform the user or others of the means for assembling the reference frame of the endoscope with respect to the accessory device as described herein. The accessory device can include a reference frame for treatment and surgery as described herein. For example, angular rotation of the treatment probe about the passageway may be performed with respect to the accessory device and components of the accessory device (such as an encoder as described herein).

Fig. 8J shows an outer shell 886 of the carrier as described herein. For example, the housing of the carrier may comprise a single piece of injection molded plastic. A single piece (such as a pair of such single pieces) may be provided in duplicate to allow assembly of the carrier housing. For example, referring to fig. 8J, a second housing can be provided having the same shape as the first piece 888 of the housing, such that the two pieces snap together on the knob and shaft and pinion as described herein to define a carrier.

Fig. 8K shows an end view of the accessory device 800 as described herein. The attachment device includes a plurality of rotatable connectors, such as a first rotatable connector 890 and a second rotatable connector 892. The first rotatable connector determines an axial position of the energy source to treat the patient. The second rotatable connector determines an angular position of the energy source relative to the shaft. For example, the energy source may comprise a gemstone (jewel) mounted on a hypodermic tube, wherein the axial position of the gemstone is determined using a first rotatable connector and the angle of the gemstone relative to the axis is determined using a second rotatable connector. The first and second rotatable connectors may be used to control both the rotational and axial positions of the energy source as described herein. An accessory device including a handpiece may include an electrical connector 894. The electrical connector may be connected to an electrical connector on the arm. The electrical connector may be used to transmit and transmit signals to and from the accessory device. The signals transmitted using the electrical connector may include electrical signals from the encoder to a controller off of the accessory device. The accessory device may include a printed circuit board 896 on which electrical connectors are disposed to connect the accessory device to the arm. The electrical connector may comprise a standard connector known in the industry. The printed circuit board may include the circuitry 898 of the handpiece. The circuitry may include a processor in the form of, for example, non-volatile memory configured to record, for example, treatment aspects (such as the treatment tables described herein) and machine parameters (such as flow rate and pressure). The high pressure saline tube 836 may include a flexible tube extending into the proximal end of the handpiece.

Fig. 8L illustrates components of an arm 900 configured to couple to the accessory device 800. The arm may include a locking mechanical connector 902 configured to couple to an accessory device and lock the accessory device in place. The arm may include a plurality of rotatable connectors 904 configured to engage the rotatable connectors of the accessory device. The arm may include an electrical connector 906 configured to connect to an accessory device. Although electrical connectors are shown, other connectors may be used, such as fiber optics or optical connectors, for example. The arm may also include a contact sensor 908 that senses contact of the accessory device and the arm.

The circuitry of the arm and the accessory device may be configured in one or more of a number of ways that facilitate connection of the accessory device to the arm. Alternatively or in combination, the accessory device can be configured to include a consumable device, such as a single use device. In many embodiments, the contact sensor is coupled to circuitry configured to rotate the rotatable connector on the arm in response to the contact sensor engaging the accessory device. The rotatable connector rotates back and forth through a predetermined range of motion when the contact sensor engages the accessory device to allow mating connection of the rotatable connector on the arm with the rotatable connector on the accessory device. In many embodiments, the rotatable connector on the arm includes a plurality of hex sockets and the accessory device includes a plurality of hex cross-sectional protrusions to engage the sockets of the arm. Alternatively, the socket and the protrusion may be reversed such that the socket is provided on the attachment means and the protrusion is provided on the arm or a combination thereof. Once the rotatable connector engages the rotatable connector of the accessory device, circuitry within the arm may detect the movement using a sensor located on the accessory device and stop rotation of the rotatable connector when coupling of the arm to the accessory device is completed.

Fig. 8M shows a view of the upper side of the accessory device 800 according to an embodiment. For example, the upper side of the accessory device may be positioned opposite the side having the rack and pinion. The attachment means may comprise a measurement gauge 801 and an indicator 803 (such as an LED) to indicate the position of the energy source on the carrier probe including the treatment probe. In many embodiments, the indicator is mounted on an inner linkage that moves in an axial direction to treat the patient. The LED indicator on the probe can inform the user of the position of the treatment probe. The measurement gauge may comprise one or more of a number of units and typically includes a one-to-one scaling with the movement of the probing tip. For example, the measurement scale may be in units such as centimeters, millimeters, or other units of length.

Fig. 8N shows components of an arm 900 according to an embodiment. The part of the arm may comprise an attachable part of the arm, comprising the user input device 910. The user input device may include a first input 912 to increase the intensity of the energy source and a second input 914 to decrease the intensity of the energy source. For example, when the energy source comprises a flow of liquid, the increase in the intensity of the energy source may comprise an increase in the flow rate of the energy source and/or an increase in the pressure of the energy source. For example, the energy source intensity reduction may include an energy source flow rate reduction or a pressure reduction, and combinations thereof.

Fig. 8O2 and 8O1 illustrate the internal structure of the arm member shown in fig. 8N. Fig. 8O1 shows the circuit 916 of the lower part of the component. The circuitry may be coupled to a connector 906, the connector 906 being coupled to an accessory device. For example, the circuitry may comprise circuitry as described herein and may comprise one or more of many known circuit components (such as a processor), memory (such as random access memory) and gate arrays (such as field programmable gate arrays). The circuit may include one or more of many known components for controlling the motor. Fig. 8O2 shows a motor 918 of an arm according to an embodiment. The motor may include known motor components configured to drive a surgical instrument. The motor may comprise a shaft extending to a protrusion of a rotatable connector as described herein. The motor may engage the accessory device when the accessory device is connected to the arm.

Circuitry coupled to the connector as shown in fig. 8O1 can be used to control the motor to position the energy source at a desired axial position and rotational angle about the shaft. The circuitry may include one or more instructions to transmit a signal to an encoder located on the accessory device to measure the angular position of the probe rotating about the shaft. Rotation of the energy source about the axis may be fed back into the circuit and the circuit may drive the energy source to a plurality of positions according to instructions of a therapy table as described herein. By locating the circuitry and motor in a reusable position on the arm, the cost and complexity of the accessory device including the handpiece can be significantly reduced.

Fig. 8P illustrates a link 804 of an accessory device 800 according to an embodiment. The linkage shown in fig. 8P may include one or more components configured to direct an energy source to a desired location and angle on the distal end of carrier 846 including the treatment probe. A carrier carrying an energy source near the distal end is coupled to the linkage to control the position and angle of the energy source on the end of the carrier. The carrier may comprise, for example, a hypodermic tube, and the energy source may comprise one or more of a number of energy sources as described herein. For example, the energy source may include a nozzle formed in a material including a jewel. The jewel on the hypodermic tube can contain high pressure fluid from the cable 836. The carrier is connected to a flexible conduit that receives energy along a flexible high-pressure pipe using a medium such as high-pressure brine. The carrier is connected to the linkage such that the carrier translates and rotates in response to commands from the circuit.

The linkage includes a first rotatable connector 890 that controls the Z-axis position along the elongated shaft of the carrier and a second rotatable connector 892 that controls the angle of the energy source relative to the elongated shaft. The first rotatable connector 890 may be rotatably connected to a plurality of threads 889. Rotation of the threads may drive the linkage proximally and distally as indicated with arrow 891. The threads, when rotated, may cause the carrier 846 to move proximally and distally as shown. As the carrier moves proximally and distally, the second rotatable connector 892 may slide along an elongated structure, such as a hexagonal structure 895. Sliding of the carrier in the axial direction may be provided for a treatment range of up to about 7 mm, for example. The second rotatable connector 892 may be rotated to cause rotation of the carrier. For example, rotation of the second rotatable connector may cause angular rotation of the carrier as shown by rotation arrow 893. Rotation of the second rotatable connector may rotate the gear 805 coupled to the link of the carrier 846. The gear of the linkage may be concentric with the carrier to cause rotation of the carrier about the elongate axis of the carrier. The second rotatable connector may include a second gear concentric with the rotatable connector to cause rotation of the gear concentric with the carrier. The linkage may include an idler gear, for example, between the first gear and the second gear, to cause angular rotation of the energy source relative to the elongate shaft of the carrier.

Fig. 8Q shows the encoder 807 mounted on the proximal end of the carrier 846. An encoder on the proximal end of the carrier may allow for accurate rotational positioning of the energy source angle. The carrier may be rotated to a target position in response to a signal measured from the encoder. The encoder on the proximal end of the carrier may comprise one or more of a number of known encoders. In many embodiments, the encoder comprises a gray encoder configured to provide the quadrature measurement. The encoder may be provided on the face of the carrier, for example, using a ring-shaped structure extending from the carrier to provide an accurate surface to which the encoder is affixed. Also, the photodetectors 809 can be arranged in a line extending along the direction of the carrier probe axis. This may facilitate measurement of the angle of the energy source and may allow detection to be located on the plane of the printed circuit board. The encoder may extend over a face of the carrier probe and the carrier probe may comprise a removable carrier treatment probe. The removable carrier treatment probe can extend into the seal as described herein. In many embodiments, the encoder includes an alignment structure that can be aligned with an energy source carried on the distal tip of the probe to ensure accurate alignment during the manufacturing process. For example, the encoder may include a plurality of edge transitions in which each edge extends in an axial direction. One or more of the edges can be preconfigured to align with an angle of an energy source extending from the elongate shaft of the probe. For example, the energy source may extend from the axis in a radial direction at the same angle as the rim extends radially from the probe, or be positioned along an angle extending radially from the probe.

Fig. 8R1 shows an encoder 807 according to an embodiment. As shown with the encoders, each of the edges 811 corresponds to an angular reference with respect to the probe. For example, a zero degree reference 813 is shown. The zero degree reference is aligned with an energy source extending from a distal end of the carrier.

FIG. 8R2 shows a table 815 showing coordinate references for different turns (transitions) measured with multiple photodetectors. These positions may give the absolute position of the probe within a certain range. A circuit as described herein may be configured to be inserted within the location shown in fig. 8R 2. This insertion may be performed in one or more of a number of ways. For example, the motor may comprise a stepper motor that provides insertion. Alternatively, the motor may include an encoder within the motor that may be used to provide insertion.

The white areas of table 815 correspond to the steel tube portion of the encoder, while the black areas correspond to the black plastic tube portion of the encoder. The steel tube and the black plastic tube may form a plurality of rows distributed along the longitudinal axis of the encoder, each row extending around the circumference of the encoder. Each row may be aligned with one photodetector. For each photodetector a (far side), B, C, and D (near side), the rotational position of the encoder corresponding to the white area may correspond to an "on" or binary code "1", while the rotational position of the encoder corresponding to the black area may correspond to an "off" or binary code "0".

The configurations of the encoders and photodetectors in fig. 8Q, 8R1, and 8R2 are provided by way of example only, and many other configurations are possible. For example, although fig. 8Q, 8R1, and 8R2 illustrate encoders comprising 4 rows (where each row is aligned with one of the 4 photodetectors), the encoders may have any number of rows aligned with any number of photodetectors in any suitable configuration. The encoder may comprise one or more additional rows and additional photodetectors aligned with each additional encoder row to increase the resolution of the encoder and thereby provide finer adjustable position adjustment of the motor and hence the carrier.

Fig. 8S illustrates a suction port 817 on the distal end 819 of the support 806, under an embodiment. The distal end of the support includes a plurality of ports 817 for drawing material from the surgical site. The plurality of ports may be sized to receive tissue resected with the energy source 848. The port may be positioned at a predetermined location to provide visual guidance to the user. For example, the suction ports may be positioned at one centimeter intervals so that a user can easily determine the size and location of tissue at the target site. For example, the user may also assess accuracy and verify the accuracy of the probe during use. The support may include a plurality of ports, for example from 2 to about 10 in number. The plurality of ports may be positioned on a bottom surface of the support facing the carrier 846. The concave shape of the support member may improve alignment and provide space to accommodate the probe. For example, a suction port on the distal end of the support may be fluidly coupled to a suction port on the proximal end of the support near the liner (826 in fig. 8A) with a channel extending from the port to the plurality of ports. The carrier of the energy source may slide towards the distal end of the support during treatment. The port may provide a reference structure to determine the position of the carrier with respect to the energy source and may help facilitate alignment during treatment. The plurality of ports on the distal end of the support may be visible, for example, ultrasonically, and may be visible, for example, using an endoscope having a field of view as described herein. The plurality of ports may be positioned between the ball portion on the distal end and the fixed portion of the tube. As described herein, the carrier probe may be advanced to the distal end of the support and retracted. As shown in fig. 8S, the carrier of the energy source is shown in a retracted position. Coupling structure 814 coupling the endoscope to elongate tube 808 is also shown retracted. The proximal portion 812 of the tube is shown having received the distal portion 810 of the tube therein such that a portion of the irrigation port 824 is covered with the proximal portion of the tube. A coupling 814 as described herein may be used to advance an elongate tube and endoscope as described herein. For example, the carrier including the energy source may be moved independently of the endoscope and coupling in the tube. In at least some embodiments, this independent movement can aid in treatment. Alternatively or in combination, the coupling may be positioned above the energy source to act as an energy source shield for a user of the system. For example, the coupling may slide over the energy source to block the energy source when the system is initially set up. In many embodiments, the coupling includes sufficient mechanical strength to withstand the energy source, and the energy source is configured to ablate tissue and also not damage the coupling when the coupling is positioned over the energy source.

Fig. 8T illustrates a console 920 according to an embodiment. The console includes a plurality of inputs and a plurality of outputs that allow a user to program the system to perform a treatment. The console includes an angle input 922 that increases the angle and a second angle input 924 that decreases the angle. The console includes an activation input 926 that activates the (prime) pump. The console includes a mode input 928 to set the mode. The console includes a suction input 930 for suction. The console includes outputs such as a docking (dock) configuration 932, an arm state 934, and a fault state 936. Power to the energy source may be increased or decreased as shown with plus 938 and minus 940. Inputs for foot switch 942 and hand control 944 are shown. As described herein, the foot pedal may comprise a standard commercially available foot switch, and the hand control may comprise plus and minus controls on the arm. The high pressure tube may be attached to a channel or connector 946 coupled to the high pressure pump.

Figures 9A and 9B show side and top views, respectively, of the treatment probe shaft aligned with the sagittal plane of the imaging probe. Figure 9A shows the treatment probe 450 tilted relative to the imaging probe 460. The imaging probe includes an elongated shaft 461 that provides a reference for the image. In many embodiments, the imaging probe includes an elongate shaft. The imaging probe may comprise an ultrasound probe having an elongated axis that at least partially defines a sagittal image plane 950. In many embodiments, the imaging probe includes a sagittal image field of view, and the treatment probe is substantially aligned with the sagittal plane of the imaging probe when the treatment probe 450 is within the field of view of the sagittal image.

Although reference is made herein to a transrectal ultrasound (TRUS) imaging probe, the imaging probe may comprise one or more of many known probes, such as, for example, a non-TRUS probe, an ultrasound probe, a magnetic resonance probe, and an endoscopic or fluoroscopic approach.

The user can align the treatment probe with the imaging probe using an image of the treatment probe obtained with the imaging probe. In the axial mode, the treatment probe is distorted when the imaging probe is not sufficiently aligned with the treatment probe. The distortion of the treatment probe may depend on the cross-sectional shape of the treatment probe. For example, a disc-shaped cross-sectional profile may appear as a distorted crescent shape in axial mode. In a sagittal imaging mode, only a portion of the elongate probe extending through the sagittal field of view will appear in the image. The user may be prompted to align the probe until sufficient alignment is reached to view the treatment probe, for example, in a view condition of the elongate treatment probe with suppressed distortion of the treatment probe in an axial mode and a substantial axial distance (e.g., 5cm) along the probe in a sagittal image.

In many embodiments, as shown in fig. 9B, the elongate axis 451 of the elongate treatment probe 450 is substantially aligned with the sagittal image plane 950 when a substantial portion (e.g., 5mm) of the elongate treatment probe is visible in the sagittal image.

Fig. 9C and 9D show side and top views, respectively, of the treatment probe 450 across the field of view of the sagittal image plane 950. For example, the user may be prompted to enhance the alignment of the configuration similar to fig. 9A and 9B.

There may be software instructions of the processor to correct for residual alignment errors in response to images of the treatment probe measured with the imaging probe. In many embodiments, the elongate shaft of the treatment probe may appear to rotate in the image. The system software may be configured to measure the rotation and rotate the image. For example, a user may be trained to view sagittal images in which the axis of the imaging probe is used as a reference. However, to plan the treatment, the user may make the treatment better visible, for example when the elongate axis of the treatment probe appears horizontally on the user screen or vertically. In many embodiments, the software measures the rotation angle of the treatment probe in an image (such as a TRUS image) and rotates the image in response to the rotation of the treatment probe. For example, the system software may measure a 1 degree rotation angle and rotate the image accordingly so that the rotation angle appears to the user to be zero degrees.

Fig. 10A-10T show treatment screens of a device according to an embodiment.

FIG. 10A illustrates a launch verification screen according to an embodiment. The launch verification screen includes a user input for a user to click the continue button when the launch is completed. This priming is performed to start the pump. It may be used to provide a source of energy such as a fluid stream. Although reference is made to a pump, the energy source may, for example, comprise another energy source or an alternative energy source (such as an electrical energy source). Upon completion of the launch, the user clicks continue.

Fig. 10B illustrates a wait for docking screen according to an embodiment. With FIG. 10B, the user is prompted to dock the system. The system may be docked by placing the accessory on an arm as described herein. Once the accessory has been docked to the arm, the system automatically proceeds to the next step.

In many embodiments, during the docking step, a rotational coupling of the arm may be provided to align the coupling of the arm with an accessory comprising a handpiece as described herein.

Fig. 10C shows a prompt for the user to confirm that the ultrasound is in a landscape view. The screen may provide an ultrasound image of a transverse view to orient the user and confirm that the ultrasound probe is in the proper transverse view. Once the user has seen the ultrasound system and confirmed that the ultrasound is in a landscape view, the screen of the user interface provides a continue button that allows the user to provide input. While the input continues, the user is prompted for the next screen.

Fig. 10D shows an angle selection input screen. The selection angle input screen allows the user to select a treatment angle. The input screen includes a plurality of icons; a first icon showing an increasing angle and a second icon showing a decreasing angle. The user clicks on the appropriate icon using an input device, such as a cursor or mouse, to increase the angle. For example, if the user desires to increase the angle, the user clicks on an icon that includes an outwardly extending arrow to increase the treatment angle. Once the treatment angle has been selected, the user may enter a confirmation by clicking on the confirmation button. Selecting an angle in the transverse view allows the user to adjust the treatment angle for the patient's anatomy. For example, the treatment angle may range from about 1 degree to 180 degrees. In many embodiments, the treatment angle is in the range from about 10 degrees to about 170 degrees.

Fig. 10E illustrates an angle selected according to an embodiment. In fig. 10E, for example, a selection angle of 80 degrees is shown. Once the user has selected the desired angle, the user can click a confirmation button to move on the next user input screen.

Fig. 10F shows a prompt for the user to change the ultrasound to a sagittal view. When changing the ultrasound to a sagittal view, the user may click the continue button with an input device such as a mouse or touch screen display. The input shown for the user may show an icon that displays a sagittal ultrasound view for the user to orient for the sagittal view.

FIG. 10G shows a probe scale user input screen. The probe zoom user input screen may be used to set the probe dimensions associated with the ultrasound image. The probe can be seen in the upper right corner of the sagittal image. A crosshair may be placed over the movable markers to identify the probe. In many embodiments, the user is prompted to identify the probe tip by placing a cross hair over the probe tip. When the user has placed a reticle over the probe tip, the instrument receives a command from the input that the probe tip has been identified.

When the probe tip has been identified, the instrument advances the carrier probe to a distal position.

Fig. 10H shows the carrier probe tip advanced to a distal position. The carrier probe tip can be viewed with a marker identifying the end of the carrier probe tip. The user may be prompted to identify the carrier probe tip in the second configuration. As shown in fig. 10H, a first position of the carrier probe tip (which is a proximal position) is shown as with a marker, and a second position of the carrier probe tip (which is a distal position) is shown as with a second marker.

While the carrier may be configured in one or more of a number of ways to perform calibration and image-guided definition of therapy as described herein, a probe including a support as described herein is employed in many embodiments.

Referring again to fig. 10G, the probe tip can be seen in a proximal position with substantial differences from the distally extending elongated support. As can be seen in fig. 10H, the probe tip extends a substantial distance closer to the distal end of the elongated support as described herein.

When the user is satisfied with the marker, the user may click on an acceptance input to accept the marker. If the user does not like the mark, the user can click on the clear button to repeat the step and identify the appropriate mark on the probe in the first and second positions.

As shown in fig. 10I, the calibration of the probe is repeated. The user input screen shows the probe scale icon used to identify the scale on the probe, and the user again places the cross hair line on the probe to mark the start and end positions. A total of three comparisons may be required according to some embodiments. The dimension of the probe can be calculated when setting the dimension is successfully completed up to a number of times.

FIG. 10J shows a user input screen in which the user is notified that the scale has been calculated. The user is then prompted to click the continue button to advance to the next screen.

Fig. 10K shows a screen shown on the display to confirm the scale. The basis with the dimensions determined with calibration can be shown overlaid on the ultrasound image. For example, as shown in fig. 10K, the dimension may extend a distance of 70 millimeters. The calibration and markers used can also be shown with the basis shown on the display. For example, a proximal marker and a distal marker may be shown on the display. When the distance between the proximal position and the distal position comprises about 60 mm, for example, the display may show markers at the zero position and the 60 mm position. The basis shown on the ultrasound image is presented to the user and the user has the opportunity to accept or reset the scale. If the user chooses to reset the scale, the user is prompted to set the scale again. If the user accepts and confirms the scale, the user is allowed to proceed to the next screen.

Fig. 10L illustrates a screen showing calibration cuts, according to an embodiment. This calibration cut may be performed in order to verify the accurate calibration of the system with the initial treatment before the treatment is completed. The display screen shows a prompt to the user with instructions. The user is prompted to perform a calibration cut. The user may be notified to press and hold the foot switch to advance the cut and raise the foot switch to pause or complete the treatment. As shown in fig. 10L, the basis covered by the treatment probe is shown. The treatment carrier probe including the nozzle may be initially aligned at a zero reference, for example on a precision mound as described herein. For example, a jet may be released from a nozzle and made visible using ultrasound or other imaging means as described herein, such as an endoscope.

Fig. 10M illustrates a calibration cut progression according to an embodiment. Fig. 10M shows a real-time image of the calibration switch on the screen. The probe is automatically advanced and directs the user to raise the foot pedal to pause or complete the treatment, and the display window indicates that the probe is being advanced. The probe can be advanced according to a treatment profile programmed in the device as described herein. While a real image shown in real time in relation to scale may be provided to the user, about half of the cut extension treatment may be shown, for example, with reference to fig. 10M. An image of an excised organ such as the prostate gland as shown in fig. 10M may help the user determine that the system is accurately set to complete treatment of tissue that is initially less sensitive to variability of treatment.

Fig. 10N shows a calibration cut near the distal end of the cut. As shown on the ultrasound image, the jet comprising the cold flame has advanced from a zero reference point to a position of about 60 millimeters. As shown in the real-time image, the tissue is essentially ablated with a target-calibrated cut. The screen provides input to the user confirming the treatment, and the user may indicate completion of the calibration cut by clicking a confirmation button. The user is prompted to restart or complete the calibration cut. When the user confirms that the calibration cut is completed, the user is then provided with the next input screen.

Fig. 10O illustrates a determine cut depth user interface screen according to an embodiment. A determined depth of cut input of a user interface shown on the display allows a user to set the depth of cut. Since the scaling of the ultrasound image to the treatment probe has been performed previously, the pixel coordinate reference of the image can be used to set additional references, such as the coordinate reference of the treatment contour. The user is prompted with a plurality of lines to indicate the depth of cut. A first icon showing a vertical arrow (where the first vertical arrow points up and the second vertical arrow points down) allows the user to slide an image overlay over the cut outline to allow the user to approximate the depth of the calibration cut. The user may also be provided with another input screen that allows the user to further adjust the calibration cut measurements. Once the user has confirmed the depth of cut, the user is prompted to proceed to the next user input screen. In many embodiments, the system includes multiple thresholds to determine whether the calibrated cutting depth is within the appropriate machine boundaries. For example, cutting too shallow may prompt the user with a warning and cutting too deep may prompt the user with a similar warning.

The user interface screen may include several values available to the user. For example, pressure and time may be shown to the user along with the target angle. The steps of the program may also be shown to the user to complete the program, such as setup steps such as priming the pump and docking as described herein. The planning may include angles and dimensions, and for example, the cutting may include calibration cuts and contours and the treatment may include treatment contours.

Fig. 10P illustrates an adjustable profile according to an embodiment. Fig. 10P shows a treatment profile shaped to the anatomy of the user. In the case where an ultrasound image of the prostate or other organ is shown to the user, the user may select multiple locations to adjust the treatment. For example, as shown in fig. 10P, the organ being treated may include an enlarged prostate. The enlarged prostate may extend beyond or into the bladder neck, for example (as indicated by numeral 9). The stenosis restriction of the bladder neck shown at numeral 8 can be adjusted according to the anatomy and measurement profile of the user. And the numeral 10 may show the anatomy of the prostate, for example, near the capsule, and the user may adjust the cutting profile accordingly. Allowing the user to adjust and confirm the contour lines. Adjustment and confirmation outline menus and instructions are provided to the user. The user is told to adjust the contour line boundaries and confirm to proceed down. When the user has confirmed the treatment contour shown on the ultrasound image, the user clicks the continue button to continue.

Fig. 10Q shows a start treatment screen. The start treatment screen allows the user to start treatment. The user is instructed to click on to begin treatment and to press and hold a foot switch to advance the cut. Lifting the foot switch can halt treatment. Alternatively, the user may complete the treatment. The user is shown a cutting profile adapted based on the profile provided by the user. The target cut profile may comprise an approximation of an expected profile provided by a user. While the cutting profile of the flame can be configured in many ways, in many embodiments the power of the jet can be increased so that the distance of the white flame and cavitation as described herein can be extended to a desired target distance.

Studies related to the embodiments show that: the flow rate of the jet can provide a radial cutting distance that can be substantially linearly related to the flow rate of the fluid entering the jet. In many embodiments, the surgical site is perfused with saline and the fluid stream comprising saline is released with high pressure to form shedding pulses as described herein. Because the distance of the white cold flame is significantly related to the cutting distance, a visual input regarding the cutting depth profile may be provided to the user. As the cutting depth profile changes, the rate of fluid from the jet can be changed to correspond to the cutting depth profile.

The cutting depth profile including the step shown in fig. 10Q may correspond to a step of varying the flow rate. For example, the flow rate may be set with any integer value from 0 to 10, and a calibration cut may be performed with a flow rate of 3 on any scale. Based on the user's anatomy and cutting profile, for example, the system software may determine that a flow rate of 9 is appropriate for the deepest cut, and may perform a flow rate of 8 near the bladder neck. Near the proximal and distal ends of the cut, the flow rate may increase, for example, from a value of about 3 near the distal end of the cut to a value corresponding to about 8 of the tissue in the bladder neck. And the flow rate may be reduced to, for example, about 3. Because the treatment probe including the jet is drawn proximally, the power of the pump may be reduced corresponding to the cutting profile. For example, the flow rate of the pump at any unit may be reduced from about 8 to a value of about 3 near the proximal end of the cut.

Figure 10R shows treatment with a treatment nozzle carried on the probe being aspirated proximally. As shown in fig. 10R and others, the energy source on the carrier probe is aspirated proximally to reposition the tissue. The treatment probe is continuously aspirated proximally with rotation and oscillation of the probe tip until the predetermined volume of tissue has been removed. This removal of a predetermined volume of tissue according to the cutting profile may provide a very accurate removal of tissue. In many embodiments, for example, delicate structures of the prostate (such as the capsule and nerves) may be avoided. In many embodiments, the screens seen by the user may include additional screens that may be helpful. For example, a treatment guidance window may be provided that shows the position of the energy source on the carrier with respect to the treatment axis. The treated elongate shaft can be extended from about 0mm to 6mm based on, for example, a procedure. Because the energy source is pumped proximally, an indicator showing the current location of the treatment may be shown on the screen. In many embodiments, this indicator shown on the screen may and should correspond to an indicator on the handpiece as described herein. This redundant information allows the user to verify that the instrument is performing correctly.

As described and illustrated herein, a series of steps that have been completed may be shown to a user on a screen (e.g., right hand side). For example, the user may be shown the current step as a treatment, and may also be shown several previous steps. The preceding steps may include setup steps such as start-up and docking as described herein. The preceding steps may include planning, such as setting angles and dimensions as described herein. And the preceding steps may include defining a cutting profile or parameters related to the cut, such as calibration and definition of the cutting profile.

Fig. 10S shows a treatment completion screen. Upon completion of the pre-programmed treatment, the user is presented with a treatment completion screen and has the option of returning to the adjustment profile and performing additional resections of tissue, or entering completion and moving to the next screen.

Fig. 10T shows an output data screen. The user is prompted to output the data. The processor may include instructions to output program data to the non-volatile memory.

The therapy may be stored in one or more of a number of ways. For example, the therapy may be stored on non-volatile memory (such as a flash drive). Alternatively or in combination, an accessory device as described herein may include non-volatile memory to store therapy. The stored therapy parameters may include sensed parameters measured during the therapy, such as the pressure of the therapy, the flow rate of the therapy, and the position of the probe. The stored treatment parameters may also include, for example, a treatment table. And the treatment table may provide useful information. For example, when compared to the position of the probe measured during treatment, treatment has been performed according to the treatment table for verification. When the user clicks the next screen, the user is prompted to move to the next stage.

The user interface screens of fig. 10A-10T are shown as examples of a series of screens in accordance with an embodiment. Those of ordinary skill in the art will recognize many variations based on the teachings provided herein. For example, some of the screens may be removed. Other screens may be added. Some of the screens may be combined. Some of the screens may include sub-screens. And the screens may be presented in a different order.

In many embodiments, other alignment screens may be provided. For example, the user may be required to identify the axis of the treatment probe to identify the reference axis of treatment. The user may be required to identify the markings of the treatment probe, for example to determine translational alignment of the treatment probe shaft shown on the image with the mapped treatment shown on the screen.

Fig. 11 illustrates a method 1100 of treating a patient according to many embodiments.

An imaging probe having an imaging probe shaft is provided, utilizing step 1102.

A treatment probe having a treatment probe shaft is provided, utilizing step 1104.

The imaging probe axis is aligned with the therapy probe axis, using step 1106.

Alignment of the treatment probe shaft along the sagittal plane of the imaging probe is verified, using step 1110.

The residual error is corrected, using step 1112.

Using step 1114, an angle of the treatment probe shaft relative to an imaging probe having an imaging probe is measured.

The patient image with the probe inserted into the patient is rotated in response to the angle, using step 1116.

Using step 1152, the user interface may ask the user whether the activation of the treatment probe has been completed.

Using step 1154, the user interface may wait for the treatment probe to interface with the computer operating the user interface.

With step 1156, the user interface may confirm to the user that the ultrasound imaging device is imaging the subject in a lateral view. Upon such confirmation, a main menu screen of the user interface may be shown.

Using step 1158, the user interface may allow the user to select a target angle of the treatment probe when performing the cutting procedure. The target angle may vary between 0 degrees and 180 degrees.

Using step 1160, the user interface may confirm the selected cut angle to the user.

With step 1162, the user interface can confirm to the user that the ultrasound imaging device is imaging the subject in a sagittal view.

Using step 1164, the user interface may facilitate scaling or calibration of the treatment probe by requiring the user to identify the starting and ending positions of the probe tip as it is advanced from the retracted position as shown by the ultrasound images. The start and end positions may be identified by placing start and end markers, respectively, on an image display portion of the user interface.

Using step 1166, the user interface may confirm to the user that the marked starting and ending positions of the probe tip are acceptable.

Using step 1168, the user interface may repeat the identification and acceptance of the starting and ending positions of the probe tip. In many embodiments, these steps (e.g., steps 1166 and 1168) are repeated three times to verify the calibration of the probe tip.

The user interface may confirm the scaling or calibration of the probe tip to the user, using step 1170.

Using step 1172, the probe tip may perform a calibration cut. The user interface may provide instructions regarding activating the probe tip to perform a calibration cut. Alternatively or in combination, the user interface may provide a menu or sub-menu for operating the treatment probe to perform a calibration cut. The display portion of the user interface may show a sagittal view of the target tissue when the calibration cut is performed. The treatment probe may be paused and paused during the cutting procedure.

Using step 1174, the user interface may confirm to the user that the calibration cut has been completed.

Using step 1176, the user interface may allow the user to determine and confirm the cut depth of the calibration cut. The user interface may provide a marker to enable the user to drag and drop at the cutting location and the probe location to confirm the depth of cut.

Using step 1178, the user interface may allow the user to adjust and then confirm the contour line boundaries of the final cut. The user interface may provide one or more markers to enable the user to drag and drop at desired contour line boundary points to modify the contour line boundaries as desired.

Using step 1180, the treatment probe tip may perform a final cut. The user interface may provide instructions regarding activating the probe tip to perform the final cut. Alternatively or in combination, the user interface may provide a menu or sub-menu for operating the treatment probe to perform the final cut. The display portion of the user interface may show a sagittal view of the target tissue when the final cut is performed. The treatment probe may be paused and paused during the cutting process.

With step 1182, the treatment may be completed and the user interface may provide options to, for example, repeat and/or modify the treatment and/or output history, parameters, and other information of the performed treatment to a storage medium (such as a USB drive, local data storage, or cloud-based storage).

The steps of method 1100 may be combined with the screens of fig. 10A-10T.

While the above-described steps illustrate a method 1100 of operating a treatment probe according to many embodiments, those of ordinary skill in the art will recognize many variations based on the teachings described herein. The steps can be completed in different orders. Steps may be added or omitted. Some steps may include sub-steps. Many steps may be repeated as long as the treatment is beneficial.

For example, steps associated with the performance of the calibration cut (e.g., corresponding to the screens of FIGS. 10L-10O, and/or steps 1172-1176 of the method 1100) may be omitted. If there is sufficient system performance data to provide an accurate correlation between system power and penetration depth of the resulting cut, a calibration step may not be necessary and the system may be configured to perform the therapeutic cut directly.

One or more steps of method 1100 may be performed using circuitry as described herein, for example using one or more of the processors or logic circuits of a system as described herein. The circuitry may be programmed to provide one or more steps of the method 1100, and the program may include, for example, program instructions stored on a computer-readable memory or programmed steps of logic circuitry such as with a programmable array logic or field programmable gate array. Fig. 11 illustrates a method according to an embodiment. Those of ordinary skill in the art will recognize many variations and adaptations in accordance with the teachings disclosed herein. For example, steps of the method may be removed. Additional steps may be provided. Some of the steps may include sub-steps. Some steps may be repeated. The order of the steps may be changed.

A processor as described herein may be configured to perform one or more of the steps of the method of fig. 11 and provide one or more of the user interface screens as described herein. In many embodiments, the processor is configured to perform at least a portion of one or more of the steps in response to user input on the display, and the processor may include instructions to generate and display a user interface screen as described herein.

The processor may be further configured to record each executed step of the methods described herein with respect to fig. 10A-10T and 11. A separate usage record may be maintained for each user or operator of the system, wherein all operator inputs provided during each step of the method may be recorded. The operator record may be configured to be not modifiable by operator access (e.g., recorded as a read-only file, stored in a restricted access database, backed up to a remote server, etc.). Recording all operator performed inputs and steps may provide enhanced operator accountability and provide useful reference data for system improvement and/or troubleshooting

Experiment of

FIG. 12 illustrates maximum tissue penetration depth of a cut versus flow rate through a nozzle, according to an embodiment. The maximum penetration depth corresponds substantially to the length of the cavitation bubbles of the jet containing the "cold" liquid ablating flame. The maximum tissue penetration depth of ablation corresponds directly to, and in many embodiments is linearly related to, the flow rate.

Figure 12 is an inset showing a cut of a potato as a prostate BPH model, according to an embodiment. The maximum penetration depth of the potato closely corresponds to the maximum cutting depth of BPH. The 10 different flow settings corresponding to rates ranging from about 50ml/min to about 250ml/min are shown in the figures for cutting potatoes by utilizing the nozzle and rotating probe described herein. The maximum penetration depth ranges from about 4mm at 50ml/min to about 20mm at about 250 ml/min.

In many embodiments, for a properly configured nozzle as described herein, the growth and length of the cavitation bolus constitutes a function of the flow velocity, which is proportional to the jet pressure and vice versa. As the pressure increases, the maximum erosion radius, represented as the maximum penetration depth of fig. 12, appears to increase linearly.

The high velocity cavitation jets may be formed by forcing water through the nozzle in a continuous flow or a pulsed flow using known high pressure pumps. Due to the unstable nature of the vapor cavity, the cavitation will be pulsed regardless of the type of flow produced by the pump, and the formation of cavitation will be pulsed even in a continuous flow jet as described herein. Without being bound to any particular theory, it is believed that both pulsed and continuous flowing water jets will result in an equal amount of material erosion in a given amount of time. In many embodiments, the nozzle geometry is configured to provide flow dynamics and cavitation processes as described herein. In many embodiments, the nozzle is configured to inhibit strong constriction at the water jet outlet, which may be associated with cavitation that may occur within the nozzle itself. In many embodiments, the sharp corners cause the water to separate from the walls and converge toward the nozzle centerline, which will further narrow the water jet path while reducing the frictional effects caused by the nozzle walls. This results in an increase in velocity with a corresponding pressure drop and steam cavity formation. Steam cavity formation will affect the overall flow dynamics because the eventual collapse of the steam cavity results in turbulence and can affect the depth of erosion. One of ordinary skill in the art can perform experimentation to determine the appropriate nozzle geometry and flow rate to provide tissue removal as described herein without undue experimentation.

Liquid ablation

The submerged waterjet cutting described herein has the ability to utilize cavitation phenomena to treat patients with benign hyperplasia of the prostate (BPH). The jet removes the excess soft tissue growth seen in BPH by the pressure pulse and the microjet caused by the collapsed vapor cavity. The direction of the water jet can be manipulated by changing the position and orientation of the device nozzle, for example by translating the nozzle in a back and forth direction or by rotating the nozzle up to 180 degrees.

Since steam cavity formation and its erosion strength are a function of both the injection pressure and the flow dynamics, the depth of the material can be controlled by configuring the pressure as well as the nozzle geometry. A greater injection pressure will result in a faster exit velocity. As discussed herein, the nozzle geometry may further increase velocity in accordance with the constriction, and will affect the degree of pressure drop as the waterjet is emitted by the venturi effect. These factors can result in cavitation boluses being able to grow and travel longer distances before collapsing and releasing the pressure pulses and micro-jets. The nozzle geometry and pressure settings of liquid ablation systems have been optimized to give the user precise control and ensure that the cavitation jet removes only the desired benign tissue growth.

The images provided herein illustrate how tissue erosion depth is a function of pressure, according to an embodiment. These images show smaller cavitation bolus lengths and corresponding tissue ablation depths for lower jet pressures than other images.

In many embodiments, the liquid ablation described herein is capable of removing excess tissue growth, such as BPH, while inhibiting removal and damage to arteries and veins. The pressure pulses and micro-jets created by cavitation exceed the threshold energy required to erode soft tissue growth and can cause minimal damage to blood vessels and other structures with much higher threshold energy. The repeated and concentrated pressure pulses and microjets may cause fatigue stress on the vascular system and lead to bleeding, but the fluid ablation system algorithms and treatment instructions as described herein are configured and designed to suppress such damage.

In many embodiments, the generation of harmful emboli is inhibited. For example, vapor cavity formation may benefit from the tiny air nuclei already present in the blood stream. Cavitation can cause the growth of the nuclei without introducing any additional air into the system. Furthermore, once the local jet pressure exceeds the steam pressure, the cavity will collapse, allowing the air bladder to shrink to its original core size. In many embodiments, since cavitation relies on and may be limited by the trace amount of air carried by the saline solution surrounding the urethra, emboli formation is inhibited and the vapor cavity dissipates rapidly as jet pressure begins to rise.

Liquid ablation as described herein takes advantage of this phenomenon. This natural self-limiting radius of erosion and the unique ability to precisely ablate tissue using low damage threshold energies while minimizing damage to nearby structures, such as arteries, with more dense cellular structures makes the fluid ablation described herein a useful surgical tool for treating BPH. In combination with the near isothermal nature of cavitation described herein, collateral damage can be mitigated and improved healing and higher safety profiles provided.

Fig. 13 shows the selective removal of potatoes as a model of selective tissue removal, in which porcine blood vessels were positioned over the incision in the potato. Pig blood vessels were placed on the potatoes prior to cutting, so that the pig blood vessels were exposed to a water jet with cavitation to remove the potatoes. Fluid ablation removed the soft potato tissue model (which is an approximate replacement for benign tissue growth seen in BPH) without causing severe damage to the porcine vessels.

FIG. 14 shows potatoes processed with a predetermined treatment profile and a treatment table based on user input.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

1. An apparatus for treating a patient, comprising:

an endoscope;

an elongate carrier to direct therapeutic energy to a target site, the elongate carrier comprising a proximal portion and a distal portion, the distal portion configured to direct energy to the target site, the proximal portion comprising an encoder to determine an angle of rotation of the carrier about an elongate axis of the carrier;

an elongated tube; and

an elongated support member.

2. The device of claim 1, wherein the elongate tube has an inner diameter sized to receive the endoscope and the elongate carrier, and wherein the elongate support extends axially outside of and is connected to the elongate tube from outside of the elongate tube, and wherein the elongate support extends beyond a distal end of the elongate tube.

3. The device of claim 1, wherein each of the endoscope, the elongate carrier, and the elongate support are sized for insertion into the patient, and wherein the elongate carrier and the endoscope are slidably disposed within the elongate tube, wherein the elongate support extends axially outside of the elongate tube.

4. The apparatus of claim 1, further comprising:

a handpiece, wherein the elongate carrier and the elongate tube extend from the handpiece for insertion into the patient.

5. The apparatus of claim 4, further comprising:

an arm, wherein the arm comprises a first unlocked configuration for inserting the elongate support and the elongate carrier into the patient with the handpiece and a second locked configuration for treating the patient.

6. The apparatus of claim 5, wherein the arm comprises a plurality of arm connectors coupled to a plurality of handpiece connectors on the handpiece to control rotation and translation of the elongated carrier.

7. The apparatus of claim 6, wherein the plurality of arm connectors comprise a plurality of torque transmitters that rotate and translate the elongated carrier.

8. The apparatus of claim 1, wherein the encoder is positioned on a face of the elongated carrier.

9. The device of claim 1, wherein the elongate carrier comprises an elongate tube, wherein the encoder comprises an annular structure extending circumferentially and axially around a proximal portion of the elongate tube to attach the elongate encoder to the proximal portion of the tube.

10. The apparatus of claim 9, wherein the encoder comprises a gray encoder having a pattern extending circumferentially and axially around the elongated tube.

11. The apparatus of claim 9, further comprising a plurality of detectors distributed around the elongate tube at a plurality of fixed angular and radial positions to measure rotation of the probe, and wherein the fixed angular positions correspond to angular orientation of the probe about a probe axis.

12. The apparatus of claim 11, wherein the plurality of detectors comprises four photodetectors arranged along orthogonal axes to provide an absolute angular orientation of the elongated carrier with respect to the four photodetectors.

13. The apparatus of claim 1, wherein the elongated carrier and handpiece are configured to remove the elongated carrier from the handpiece.

14. The apparatus of claim 1, wherein the encoder comprises a reference angularly aligned with an energy emission axis of the probe.

15. The apparatus of claim 14, wherein the fiducial comprises a boundary extending in an axial direction toward an energy source on the carrier, the boundary being angularly aligned with the energy source.

16. The apparatus of any one of claims 4 or 5, wherein one or more of the handpiece or the arm includes an input that increases or decreases a power setting of the therapeutic energy.

17. The apparatus of claim 15, further comprising a therapy table comprising a plurality of coordinate reference positions and a plurality of amounts of energy, and wherein a maximum power setting input with the handpiece is limited in response to the plurality of amounts of energy for each of the plurality of coordinate reference positions.

18. The apparatus of claim 1, further comprising:

19. The apparatus of claim 1, further comprising:

an accessory configured to be coupled to an arm, the accessory including the elongate tube and the elongate support, wherein the accessory is configured to receive the elongate carrier and the endoscope.

20. The apparatus of claim 19, wherein the accessory comprises a sterile accessory configured for single use.

21. The apparatus of claim 19, wherein the accessory comprises circuitry configured to provide a unique identification to identify the accessory among a plurality of accessories.

22. The apparatus of claim 21, further comprising:

23. The device of claim 22, wherein the processor includes instructions to generate a therapy table, and wherein the circuitry of the accessory includes non-volatile memory and instructions to store the therapy table in the non-volatile memory.

24. The apparatus of claim 23, wherein the circuitry of the accessory includes instructions to store one or more of a power setting of the energy source, a pressure of the energy source, or a flow rate of the energy source.

25. The apparatus of claim 22, wherein the accessory comprises a connector electrically coupled to the arm and communicating data from the circuit to the arm and from the circuit to the arm.

26. The apparatus of claim 19, wherein the attachment comprises a linkage that moves an energy source on the elongated carrier to a plurality of axial and angular positions, and wherein the attachment comprises a plurality of rotatable connectors that receive rotational movement from a plurality of connectors on the arm, the attachment comprising a plurality of encoders that measure a plurality of axial and angular positions, the attachment comprising a connector that transmits signals from the plurality of encoders to the arm, and wherein a processor off the attachment coupled to the connectors receives the signals and rotates the plurality of rotatable connectors to drive the energy source to the plurality of axial and angular positions.

27. The apparatus of claim 19, wherein the accessory includes a handpiece shaped as a part for a user to manipulate the accessory prior to locking the arm.

28. The apparatus of claim 19, wherein the accessory comprises a component of a kit configured to treat a target organ.

29. The apparatus of claim 19, wherein the arm comprises one or more of a manually movable arm or a robotic arm.